WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca advances its ambition to redefine cancer care with new data across its industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4, 2024.

在2024年5月31日至6月4日举行的美国临床肿瘤学会（ASCO）年会上，阿斯利康通过其行业领先的投资组合和渠道，推进了其重新定义癌症治疗的雄心壮志。

More than 100 abstracts will feature 25 approved and potential new medicines across the Company’s diverse oncology portfolio and pipeline, including two late-breaking plenary presentations, a special late-breaking abstract session presentation and 15 oral presentations. Highlights include:

超过100篇摘要将介绍该公司各种肿瘤学组合和管道中的25种经批准和潜在的新药，包括两次迟发性全体会议报告，一次特殊的迟发性抽象会议报告和15次口头报告。亮点包括：

LAURA Phase III trial of TAGRISSO® (osimertinib) in unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) (Plenary LBA4).

放化疗（CRT）后不可切除的III期表皮生长因子受体突变（EGFRm）非小细胞肺癌（NSCLC）中TAGRISSO®（osimertinib）的LAURA III期试验（全体LBA4）。

ADRIATIC Phase III trial of IMFINZI® (durvalumab) in patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following concurrent CRT (cCRT) (Plenary LBA5).

IMFINZI®（durvalumab）在局限期小细胞肺癌（LS-SCLC）患者中的亚得里亚海III期试验，这些患者在同时进行CRT（cCRT）后没有进展（全体LBA5）。

DESTINY-Breast06 Phase III trial of ENHERTU® (fam-trastuzumab deruxtecan-nxki) in patients with metastatic hormone receptor (HR)-positive HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy (LBA1000).

DESTINY-Breast06 ENHERTU®（fam曲妥珠单抗deruxtecan nxki）在一种或多种内分泌治疗（LBA1000）后转移性激素受体（HR）阳性HER2低和HER2超低转移性乳腺癌患者中的III期临床试验。

First-in-human, investigator-initiated trial of C-CAR031, a novel autologous armored Glypican 3 (GPC3) targeting chimeric antigen receptor T cell (CAR-T) therapy, in patients with liver cancer. The CAR-T is based on AZD5851, a novel cell therapy designed by AstraZeneca (Rapid Oral Abstract 4019).

首先在人类中，研究者启动了针对肝癌患者的新型自体装甲磷脂酰肌醇蛋白聚糖3（GPC3）靶向嵌合抗原受体T细胞（CAR-T）疗法C-CAR031的试验。CAR-T基于AZD5851，这是一种由阿斯利康（Rapid Oral Abstract 4019）设计的新型细胞疗法。

Two late-breaking presentations from the externally sponsored I-SPY2.2 Phase II trial of neoadjuvant datopotamab deruxtecan (Dato-DXd), alone and in combination with IMFINZI, in patients with breast cancer (LBA501 and LBA509).

在乳腺癌患者（LBA501和LBA509）中，来自外部赞助的新辅助达托单抗deruxtecan（Dato DXd）的I-SPY2.2 II期临床试验的两个最新突破性报告，单独或与IMFINZI联合使用。

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Our plenary data at ASCO show the pioneering role of our medicines in curative-intent lung cancer treatment and highlight progress toward our continued ambition to have a medicine for more than half of all patients treated for lung cancer by 2030.

阿斯利康肿瘤业务部门执行副总裁戴夫·弗雷德里克森（DaveFredrickson）表示：“我们在ASCO的全体会议数据显示，我们的药物在治疗意图肺癌治疗中发挥了开创性作用，并突出了我们在2030年前为超过一半的肺癌患者提供药物的持续目标方面取得的进展。

The overwhelming efficacy in the LAURA trial will add to the extensive body of evidence for TAGRISSO in EGFR-mutated non-small cell lung cancer, and the impressive survival data from ADRIATIC will show the potential of IMFINZI to transform outcomes in limited-stage small cell lung cancer.”.

LAURA试验的压倒性疗效将为TAGRISSO在EGFR突变的非小细胞肺癌中的广泛证据提供更多证据，亚得里亚海令人印象深刻的生存数据将显示IMFINZI在有限期小细胞肺癌中改变预后的潜力。”。

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Data from our antibody drug conjugates at ASCO underscore the opportunity to replace traditional chemotherapy with these medicines for many patients as we expand their use to new populations. DESTINY-Breast06 results will demonstrate the potential to treat patients across a broader spectrum of HR-positive metastatic breast cancer with ENHERTU, including those with HER2-ultralow expression who have never had access to HER2-directed therapy before.

阿斯利康肿瘤学研发执行副总裁苏珊·加尔布雷斯（SusanGalbraith）表示：“ASCO抗体药物偶联物的数据强调，随着我们将这些药物的使用扩展到新人群，许多患者有机会用这些药物替代传统化疗。DESTINY-Breast06的结果将证明用ENHERTU治疗更广泛的HR阳性转移性乳腺癌患者的潜力，包括那些以前从未接受过HER2定向治疗的HER2超低表达患者。

We're also excited by the I-SPY2.2 efficacy and tolerability data for datopotamab deruxtecan plus IMFINZI, which will show the potential of combining antibody drug conjugates with immunotherapy in the early-stage setting.”.

我们也对达托单抗deruxtecan加IMFINZI的I-SPY2.2疗效和耐受性数据感到兴奋，这将显示抗体-药物偶联物与早期免疫治疗相结合的潜力。”。

Transforming treatment expectations across earlier-stage lung cancer settings

改变早期肺癌患者的治疗期望

Several presentations will reinforce the Company’s progress toward moving lung cancer treatment to earlier stages of disease. These include:

几场演讲将加强该公司在将肺癌治疗转移到疾病早期阶段方面的进展。其中包括：

A late-breaking plenary presentation showcasing progression-free survival (PFS) results from the LAURA Phase III trial evaluating TAGRISSO in unresectable, Stage III EGFRm NSCLC after CRT. In February, high-level results showed a statistically significant and highly clinically meaningful PFS benefit for TAGRISSO in this setting..

一个最新的全体会议展示了LAURA III期试验评估TAGRISSO在CRT后不可切除的III期EGFRm NSCLC中的无进展生存期（PFS）结果。2月，高水平的结果显示，在这种情况下，塔格里索的PFS益处具有统计学意义和高度临床意义。。

A late-breaking plenary presentation highlighting overall survival (OS) and PFS results from the ADRIATIC Phase III trial of IMFINZI in patients with LS-SCLC who had not progressed following cCRT. In April, high-level results from an interim analysis showed a statistically significant and clinically meaningful OS and PFS benefit for IMFINZI in this setting..

一项最新的全体会议报告强调了IMFINZI在LS-SCLC患者中的总生存期（OS）和PFS结果，这些患者在cCRT后没有进展。4月，中期分析的高水平结果显示，在这种情况下，IMFINZI的OS和PFS获益具有统计学意义和临床意义。。

An oral presentation of an analysis from the ADAURA Phase III trial of TAGRISSO in the adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC, assessing the potential for circulating tumor DNA-based molecular residual disease to predict disease recurrence.

TAGRISSO的ADAURA III期临床试验在早期（IB，II和IIIA）EGFRm NSCLC辅助治疗中的分析的口头介绍，评估了基于循环肿瘤DNA的分子残留疾病预测疾病复发的潜力。

A rapid oral presentation of an exploratory analysis from the AEGEAN Phase III trial of IMFINZI-based treatment before and after surgery in patients with resectable early-stage (IIA-IIIB) NSCLC, evaluating efficacy in patients with N2 disease (cancer in the lymph nodes on the same side as the affected lung or between the lungs)..

对可切除早期（IIA-IIIB）NSCLC患者手术前后基于IMFINZI的爱琴海III期试验的探索性分析进行了快速口头介绍，评估了N2疾病患者（与受影响肺同侧或肺之间的淋巴结癌）的疗效。。

A poster presentation of updated OS, PFS and safety results from the COAST Phase II trial of IMFINZI in combination with novel immunotherapies oleclumab, an anti-CD73 monoclonal antibody, and monalizumab, an anti-NKG2A monoclonal antibody, in unresectable, Stage III NSCLC, supporting the PACIFIC-9 Phase III trial in this patient population..

在不可切除的III期NSCLC中，IMFINZI的COAST II期试验与新型免疫疗法-抗CD73单克隆抗体olclumab和抗NKG2A单克隆抗体monalizumab联合使用的最新OS，PFS和安全性结果的海报展示，支持该患者群体的PACIFIC-9 III期试验。。

In metastatic lung cancer, the Company will present data that underscore its commitment to extending the benefits of antibody drug conjugates (ADCs) to more patients. A poster presentation will share updated safety and efficacy results, including PD-L1 expression, from the TROPION-Lung02 Phase Ib trial of datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy as 1st-line treatment for patients with advanced NSCLC without actionable genomic alterations.

在转移性肺癌方面，该公司将提供数据，强调其致力于将抗体-药物偶联物（ADC）的益处扩展到更多患者。海报展示将分享最新的安全性和有效性结果，包括PD-L1表达，来自达托帕单抗-德鲁替康联合派姆单抗联合或不联合铂类化疗的TROPION-Lung02 Ib期试验，作为晚期非小细胞肺癌患者的一线治疗，无需可行的基因组改变。

These data build on previously presented results from the TROPION-Lung-1 Phase III trial demonstrating the potential of this novel ADC in advanced disease. Datopotamab deruxtecan in combination with immunotherapies is being further explored in multiple Phase III trials in this setting, including AVANZAR, TROPION-Lung07 and TROPION-Lung08..

这些数据建立在之前提出的TROPION-Lung-1 III期试验结果的基础上，证明了这种新型ADC在晚期疾病中的潜力。在这种情况下，包括AVANZAR，TROPION-Lung07和TROPION-Lung08在内的多个III期临床试验正在进一步探索达托巴单抗联合免疫疗法。。

Redefining the breast cancer treatment landscape with ADCs across subtypes and stages of disease

用ADC跨疾病亚型和阶段重新定义乳腺癌治疗格局

A late-breaking presentation will showcase efficacy and safety outcomes from the DESTINY-Breast06 Phase III trial. In April, high-level results showed ENHERTU demonstrated a statistically significant and clinically meaningful improvement in PFS versus standard-of-care chemotherapy in patients with HR-positive, HER2-low metastatic breast cancer.

最新的演示将展示DESTINY-Breast06 III期试验的疗效和安全性结果。四月，高水平的结果显示，在HR阳性，HER2低转移性乳腺癌患者中，ENHERTU显示PFS与标准化疗相比有统计学意义和临床意义的改善。

A clinically meaningful PFS improvement was also seen in patients with HER2-ultralow expression..

HER2超低表达患者的PFS也有临床意义的改善。。

An oral presentation will spotlight data from an interim analysis of the dose-expansion phase of the DESTINY-Breast07 Phase 1b/II trial assessing ENHERTU alone or in combination with pertuzumab as 1st-line treatment in HER2-positive metastatic breast cancer. These regimens are being further explored in the DESTINY-Breast09 Phase III clinical trial..

口头报告将重点介绍DESTINY-Breast07 1b/II期试验剂量扩展阶段的中期分析数据，该试验评估单独使用ENHERTU或与帕妥珠单抗联合作为HER2阳性转移性乳腺癌的一线治疗。这些方案正在DESTINY-Breast09 III期临床试验中进一步探索。。

Additionally, a poster presentation will share updated OS and PFS results from the DESTINY-Breast03 Phase III trial of ENHERTU versus trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane.

此外，海报演示将分享先前接受曲妥珠单抗和紫杉烷治疗的HER2阳性转移性乳腺癌患者中ENHERTU与曲妥珠单抗emtansine（T-DM1）的DESTINY-Breast03 III期试验的最新OS和PFS结果。

An oral presentation will feature patient-reported outcomes data from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan in patients with inoperable or metastatic HR-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.

口头报告将介绍来自达托帕单抗deruxtecan的TROPION-BRAST01 III期试验的患者报告的结果数据，该试验用于先前接受内分泌治疗和至少一种全身治疗的无法手术或转移性HR阳性，HER2低或阴性乳腺癌患者。

Previously presented primary results from TROPION-Breast01 showed datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS versus investigator’s choice of chemotherapy..

之前来自TROPION-Breast01的主要结果显示，与研究者选择的化疗相比，达托单抗deruxtecan在PFS方面表现出统计学上显着且具有临床意义的改善。。

Two late-breaking presentations of results from the externally sponsored I-SPY2.2 Phase II trial will highlight the rates of pathological complete response associated with neoadjuvant datopotamab deruxtecan, alone and in combination with IMFINZI, across breast cancer subtypes.

外部赞助的I-SPY2.2 II期临床试验的两个最新结果介绍将突出显示乳腺癌亚型中与新辅助达托巴单抗deruxtecan单独或与IMFINZI联合使用相关的病理完全缓解率。

Advancing the next wave of medicines and combination therapies to attack cancer from multiple angles

推动下一波药物和联合疗法从多个角度攻击癌症

A rapid oral presentation will spotlight safety and preliminary efficacy results from an investigator-initiated Trial of C-CAR031, a novel autologous armored Glypican 3 (GPC3) targeting chimeric antigen receptor T cell (CAR-T) therapy that is being investigated for hepatocellular carcinoma. The CAR-T is based on AZD5851, a novel cell therapy designed by AstraZeneca using their transforming growth factor-beta receptor II (TGFβRII) dominant negative armoring platform and is manufactured by AbelZeta Pharmaceuticals Inc.

快速的口服介绍将集中研究者发起的C-CAR031试验的安全性和初步疗效结果，C-CAR031是一种针对嵌合抗原受体T细胞（CAR-T）治疗的新型自体装甲磷脂酰肌醇蛋白聚糖3（GPC3），正在研究肝细胞癌。CAR-T基于AZD5851，这是一种由阿斯利康使用其转化生长因子β受体II（TGFβRII）显性负铠装平台设计的新型细胞疗法，由AbelZeta Pharmaceuticals Inc.制造。

C-CAR031 is being developed in China under a co-development agreement between AbelZeta and AstraZeneca. AstraZeneca’s TGFβRII dominant negative armoring is designed to resist the immuno-suppressive tumor microenvironment and enhance the potential effectiveness of CAR-Ts in solid tumors..

根据AbelZeta和AstraZeneca之间的共同开发协议，C-CAR031正在中国开发。阿斯利康的TGFβRII显性负铠装旨在抵抗免疫抑制性肿瘤微环境，并增强CAR-Ts在实体瘤中的潜在有效性。。

A rapid abstract update will feature updated efficacy data from a Phase I trial of AZD0901, a potential first-in-class ADC targeting Claudin 18.2, which has shown promise as a therapeutic target in gastric cancer. First results were presented at the ASCO Plenary Series 2023.

快速摘要更新将提供AZD0901 I期临床试验的最新疗效数据，AZD0901是一种潜在的针对Claudin 18.2的一流ADC，有望成为胃癌的治疗靶点。第一个结果是在ASCO全体会议系列2023上提出的。

Additionally, a clinical science symposium presentation of the externally sponsored CAPRI Phase II trial will share efficacy and safety results for ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, plus LYNPARZA (olaparib) in patients with platinum-sensitive recurrent high-grade serious ovarian cancer..

此外，外部赞助的CAPRI II期临床试验的临床科学研讨会将分享ceralasertib（一种共济失调毛细血管扩张症和rad3相关（ATR）激酶抑制剂）以及LYNPARZA（olaparib）在铂敏感复发性高度严重卵巢癌患者中的疗效和安全性结果。。

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialize ENHERTU and datopotamab deruxtecan, and with Merck & Co., Inc. (MSD outside of the US and Canada) to develop and commercialize LYNPARZA.

科学界的合作对于改善患者的预后至关重要。阿斯利康正在与第一三共公司合作开发ENHERTU和datopotamab deruxtecan并将其商业化，并与默克公司（美国和加拿大以外的MSD）合作开发LYNPARZA并将其商业化。

AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialization agreement initiated in 2015..

2018年10月，阿斯利康通过2015年启动的共同开发和商业化协议，从先天制药公司获得了monalizumab的全部肿瘤学权利。。

Key AstraZeneca presentations during ASCO 2024

AstraZeneca在ASCO 2024期间的主要演讲

Lead Author

主要作者

Abstract Title

摘要标题

Presentation details (CDT)

演示详细信息（CDT）

Lung Cancers

肺癌

Ramalingam, SS

Ramalingam，SS

Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study.

不可切除（stg）III期表皮生长因子受体突变（EGFRm）NSCLC患者（pts）确定性放化疗（CRT）后的Osimertinib（osi）：3期LAURA研究的主要结果。

Abstract #LBA4

摘要#LBA4

Plenary Session

全体会议

June 2, 2024

2024年6月2日

2:47pm

2： 下午47点

Spigel, DR

Spigel，DR

ADRIATIC: durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC).

亚得里亚海：durvalumab（D）作为有限期小细胞肺癌（LS-SCLC）患者（PT）的巩固治疗（tx）。

Abstract #LBA5

摘要#LBA5

Plenary Session

全体会议

June 2, 2024

2024年6月2日

3:21pm

3： 21点

John, T

约翰，T

Molecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR‑mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).

切除EGFR突变（EGFRm）IB-IIIA期非小细胞肺癌（NSCLC）患者（pts）辅助（adj）osimertinib ADAURA试验的分子残留病（MRD）分析。

Abstract #8005

摘要#8005

Oral Abstract Session

口头摘要会议

June 3, 2024

2024年6月3日

9:12am

9： 上午12点

Heymach, J

海马赫，J

Outcomes with perioperative durvalumab (D) in pts with resectable NSCLC and baseline N2 lymph node involvement (N2 R-NSCLC): An exploratory subgroup analysis of AEGEAN.

围手术期durvalumab（D）在可切除NSCLC和基线N2淋巴结受累（N2 R-NSCLC）患者中的结果：爱琴海的探索性亚组分析。

Abstract #8011

摘要#8011

Rapid Oral Abstract Session

快速口头摘要会议

June 2, 2024

2024年6月2日

4:36pm

4： 下午36点

Aggarwal, C

阿加瓦尔，C

Updated results from COAST, a phase 2 study of durvalumab (D) ± oleclumab (O) or monalizumab (M) in patients (pts) with stage III unresectable non-small cell lung cancer (uNSCLC).

来自COAST的最新结果，这是一项针对III期不可切除非小细胞肺癌（uNSCLC）患者（pts）的durvalumab（D）±oleclumab（O）或monalizumab（M）的2期研究。

Abstract #8046

摘要#8046

Poster Session

海报会议

June 3, 2024

2024年6月3日

1:30pm

1： 下午30点

Levy, BP

利维，英国石油公司

Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC): Subgroup analysis from TROPION-Lung02.

达托巴单抗（Dato DXd）加pembrolizumab（pembro）联合或不联合铂类化疗（Pt-CT）作为晚期非小细胞肺癌（aNSCLC）的一线（1L）治疗：来自TROPION-Lung02的亚组分析。

Abstract #8617

摘要#8617

Poster Session

海报会议

June 3, 2024

2024年6月3日

1:30pm

1： 下午30点

Janne, PA

Janne，PA

Trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant metastatic non–small cell lung cancer (mNSCLC): Final analysis results of DESTINY-Lung02.

HER2突变转移性非小细胞肺癌（mNSCLC）患者的曲妥珠单抗-德鲁替康（T-DXd）：DESTINY-Lung02的最终分析结果。

Abstract #8543

摘要#8543

Poster Session

海报会议

June 3, 2024

2024年6月3日

1:30pm

1： 下午30点

Sun, Y

太阳，Y

Datopotamab deruxtecan (Dato-DXd) in Chinese patients (pts) with advanced or metastatic non-small cell lung cancer (NSCLC): Results from the phase 1/2 TROPION-PanTumor02 study.

中国晚期或转移性非小细胞肺癌（NSCLC）患者（pts）中的达托巴单抗（Dato DXd）：1/2期TROPION-PanTumor02研究的结果。

Abstract #8548

摘要#8548

Poster Session

海报会议

June 3, 2024

2024年6月3日

1:30pm

1： 下午30点

Lisberg, A

Lisberg，A

Intracranial efficacy of datopotamab deruxtecan (Dato-DXd) in patients (pts) with previously treated advanced/metastatic non-small cell lung cancer (a/m NSCLC) with actionable genomic alterations (AGA): Results from TROPION-Lung05.

达托单抗-德鲁替康（Dato-DXd）对先前治疗的晚期/转移性非小细胞肺癌（a/m NSCLC）患者（pts）的颅内疗效（AGA）：来自TROPION-Lung05的结果。

Abstract #8593

摘要#8593

Poster Session

海报会议

June 3, 2024

2024年6月3日

1:30pm

1： 下午30点

Sands, J

桑兹，J

Analysis of drug-related interstitial lung disease (ILD) inpatients (pts) treated with datopotamab deruxtecan (Dato-DXd).

达托单抗（Dato DXd）治疗药物相关性间质性肺病（ILD）住院患者（pts）的分析。

Abstract #8623

摘要#8623

Poster Session

海报会议

June 3, 2024

2024年6月3日

1:30pm

1： 下午30点

Breast Cancers

乳腺癌

Curigliano, G

Curigliano，G

Trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow metastatic breast cancer (mBC) with prior endocrine therapy (ET): Primary results from DESTINY-Breast06 (DB-06)..

曲妥珠单抗-德鲁替康（T-DXd）与激素受体阳性（HR+）、人表皮生长因子受体2（HER2）-低或HER2-超低转移性乳腺癌（mBC）患者既往内分泌治疗（ET）的医生选择化疗（TPC）：DESTINY-Breast06（DB-06）的主要结果。。

Abstract #LBA1000

摘要#LBA1000

Oral Abstract Session

口头摘要会议

June 2, 2024

2024年6月2日

7:30am

7： 上午30点

Pernas, S

腿部，S

Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Patient-reported outcomes (PROs) from the TROPION-Breast01 study.

Datopotamab deruxtecan（Dato DXd）与化疗（CT）在先前治疗的不可手术或转移性激素受体阳性，HER2阴性（HR+/HER2-）乳腺癌（BC）中的比较：来自TROPION-Breast01研究的患者报告结果（PRO）。

Abstract #1006

摘要#1006

Oral Abstract Session

口头摘要会议

June 1, 2024

2024年6月1日

4:24pm

4： 下午24点

Andre, F

安德烈，F

DESTINY-Breast07: Dose-expansion interim analysis of T-DXd monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ mBC.

DESTINY-Breast07:T-DXd单药治疗和T-DXd+帕妥珠单抗治疗先前未治疗的HER2+mBC患者的剂量扩展中期分析。

Abstract #1009

摘要#1009

Oral Abstract Session

口头摘要会议

June 1, 2024

2024年6月1日

5:24pm

5： 下午24点

Shatsky, RA

沙茨基，RA

Rates of pathologic complete response (pCR) after datopotamab deruxtecan (Dato) plus durvalumab (Durva) in the neoadjuvant setting: Results from the I-SPY2.2 trial.

新辅助治疗中达托单抗-德鲁替康（Dato）加durvalumab（Durva）后的病理完全缓解率（pCR）：I-SPY2.2试验的结果。

Abstract #LBA501

摘要#LBA501

Oral Abstract Session

口头摘要会议

June 3, 2024

2024年6月3日

3:12pm

3： 下午12点

Meisel, J

Meisel，J

Rates of pathologic complete response (pCR) after neoadjuvant datopotamab deruxtecan (Dato): Results from the I-SPY2.2 trial.

新辅助达托单抗-德鲁替康（Dato）后的病理完全缓解率（pCR）：I-SPY2.2试验的结果。

Abstract #LBA509

摘要#LBA509

Rapid Oral Abstract Session

快速口头摘要会议

May 31, 2024

2024年5月31日

2:45pm

2： 下午45点

Hamilton, EP

汉密尔顿，EP

Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with HER2+ metastatic breast cancer (mBC): Updated survival results of DESTINY-Breast03.

HER2+转移性乳腺癌（mBC）患者（pts）中曲妥珠单抗-德鲁替康（T-DXd）与曲妥珠单抗-恩他辛（T-DM1）：DESTINY-Breast03的最新生存结果。

Abstract #1025

摘要#1025

Poster Session

海报会议

June 2, 2024

2024年6月2日

9:00am

9： 上午00点

Gastrointestinal Cancers

胃肠道癌症

Zhang, Q

张，Q

Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC).

C-CAR031（一种GPC3特异性TGFβRIIDN装甲自体CAR-T）在晚期肝细胞癌（HCC）患者中的I期研究。

Abstract #4019

摘要#4019

Rapid Oral Abstract Session

快速口头摘要会议

June 3, 2024

2024年6月3日

10:51am

10： 上午51点

Xu, RH

徐，RH

Updates on Abstract 434420: A Phase 1 Trial of Claudin 18.2-Specific Antibody-Drug Conjugate CMG901 in Patients with Advanced Gastric/Gastroesophageal Junction Cancer

摘要434420的更新：Claudin 18.2特异性抗体-药物偶联物CMG901在晚期胃/胃食管交界癌患者中的1期试验

Education Session

教育课程

June 1, 2024

2024年6月1日

12:42pm

12： 下午42点

Chan, SL

陈，SL

Safety analysis by treatment periods from EMERALD-1: A phase 3, randomized, placebo-controlled study of transarterial chemoembolization with durvalumab with/without bevacizumab in participants with embolization-eligible unresectable hepatocellular carcinoma.

EMERALD-1治疗期的安全性分析：一项3期随机安慰剂对照研究，在栓塞合格的不可切除肝细胞癌患者中，使用durvalumab联合/不联合贝伐单抗进行动脉化疗栓塞。

Abstract #4122

摘要#4122

Poster Session

海报会议

June 1, 2024

2024年6月1日

1:30pm

1： 下午30点

Kelley, RK

Kelley，RK

T cell receptor and immune gene expression pharmacodynamics for durvalumab monotherapy and in combination with tremelimumab or bevacizumab in unresectable hepatocellular carcinoma (uHCC).

durvalumab单药治疗和联合tremelimumab或贝伐单抗治疗不可切除肝细胞癌（uHCC）的T细胞受体和免疫基因表达药效学。

Abstract #4022

摘要#4022

Poster Session

海报会议

June 1, 2024

2024年6月1日

1:30pm

1： 下午30点

Hamilton, A

汉密尔顿，A

ATHENA: A phase 1/2 study of AZD5851, a chimeric antigen receptor (CAR) T-cell therapy directed against GPC3 in adult patients with advanced/recurrent hepatocellular carcinoma (HCC).

雅典娜：AZD5851的1/2期研究，AZD5851是一种针对晚期/复发性肝细胞癌（HCC）成年患者GPC3的嵌合抗原受体（CAR）T细胞疗法。

Abstract #TPS2675

摘要#TPS2675

Poster Session

海报会议

June 1, 2024

2024年6月1日

9:00am

9： 上午00点

Shen, L

沈，L

GEMINI-Gastric: A phase 2 study of novel treatment combinations in patients with locally advanced unresectable or metastatic gastric cancers.

双子座胃癌：局部晚期不可切除或转移性胃癌患者新型治疗组合的2期研究。

Abstract #TPS4182

摘要#TPS4182

Poster Session

海报会议

June 1, 2024

2024年6月1日

1:30pm

1： 下午30点

Zhou, J

周，J

GEMINI-Hepatobiliary: A phase 2 study of novel first-line immuno-oncology-based treatments in patients with advanced hepatobiliary cancers.

GEMINI肝胆：一项针对晚期肝胆癌患者的新型一线免疫肿瘤学治疗的2期研究。

Abstract #TPS4187

摘要#TPS4187

Poster Session

海报会议

June 1, 2024

2024年6月1日

1:30pm

1： 下午30点

Gynecological Cancers

妇科癌症

Simpkins, F

辛普金斯，F

Combination ATR and PARP Inhibitor (CAPRI): A phase 2 study of ceralasertib plus olaparib in patients with recurrent, platinum-sensitive epithelial ovarian cancer (cohort A).

ATR和PARP抑制剂联合治疗（CAPRI）：ceralasertib联合olaparib治疗复发性铂类敏感性上皮性卵巢癌患者的2期研究（队列A）。

Abstract #5510

摘要#5510

Clinical Science Symposium

临床科学研讨会

June 1, 2024

2024年6月1日

1:39pm

1： 下午39点

Pan-Tumor

泛肿瘤

Raufi, AG

Raufi股份公司

CLARITY-PanTumor01: A phase 2 trial of the claudin 18.2-specific antibody-drug conjugate AZD0901 (CMG901) in patients with CLDN18.2-expressing advanced solid tumors.

CLARITY-PanTumor01：claudin 18.2特异性抗体-药物偶联物AZD0901（CMG901）在表达CLDN18.2的晚期实体瘤患者中的2期临床试验。

Abstract #TPS3163

摘要#TPS3163

Poster Session

海报会议

June 1, 2024

2024年6月1日

9:00am

9： 上午00点

Punekar, SR

Punekar，SR

An open-label, phase 1, multicenter study to evaluate the safety and preliminary anti-tumor activity of NT‑112 in human leukocyte antigen-C*08:02–positive adult patients with unresectable, advanced, and/or metastatic solid tumors that are positive for the KRAS G12D mutation.

一项开放标签的1期多中心研究，旨在评估NT-112在人类白细胞抗原-C*08:02阳性成人患者中的安全性和初步抗肿瘤活性，这些患者患有不可切除，晚期和/或转移性实体瘤，KRAS G12D突变呈阳性。

Abstract #TPS2677

摘要#TPS2677

Poster Session

海报会议

June 1, 2024

2024年6月1日

9:00am

9： 上午00点

Spira, AI

Spira，AI

PRIMROSE: A modular phase 1/2a study of AZD3470, an MTA-cooperative PRMT5 inhibitor, in patients with MTAP deficient advanced solid tumors.

报春花：MTA协同PRMT5抑制剂AZD3470在MTAP缺陷型晚期实体瘤患者中的模块化1/2a期研究。

Abstract #TPS3179e

摘要#TPS3179e

Poster Session

海报会议

June 1, 2024

2024年6月1日

9:00am

9： 上午00点

Perez, A

Perez，A

Non-clinical evaluation of NT-175, an autologous T cell product engineered to express an HLA-A*02:01-restricted TCR targeting TP53 R175H and resistant to TGF-b inhibition.

NT-175的非临床评估，NT-175是一种自体T细胞产物，经工程改造可表达靶向TP53 R175H的HLA-A*02:01限制性TCR，并对TGF-b抑制具有抗性。

Abstract #2560

摘要#2560

Poster Session

海报会议

June 1, 2024

2024年6月1日

9:00am

9： 上午00点

IMPORTANT SAFETY INFORMATION FOR TAGRISSO® (osimetinib)

TAGRISSO®（osimetinib）的重要安全信息

There are no contraindications for TAGRISSO

塔格里索没有禁忌症

Interstitial lung disease (ILD)/pneumonitis occurred in 4% of the 1813 TAGRISSO-treated patients; 0.4% of cases were fatal. In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal.

1813例TAGRISSO治疗患者中有4%发生间质性肺病（ILD）/肺炎；0.4%的病例是致命的。在FLAURA2研究中，276例接受TAGRISSO联合培美曲塞和铂类化疗的患者中，ILD/肺炎发生率为3.3%；0.4%的病例是致命的。

Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (eg, dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed.

对于出现可能指示ILD（例如呼吸困难，咳嗽和发烧）的呼吸道症状恶化的患者，停止使用TAGRISSO并立即调查ILD。如果确诊ILD/肺炎，则永久停用TAGRISSO。

Heart rate-corrected QT (QTc) interval prolongation occurs in TAGRISSO-treated patients. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec.

TAGRISSO治疗的患者发生心率校正的QT（QTc）间隔延长。在临床试验中，1813名接受TAGRISSO单药治疗的患者中，1.1%的患者QTc>500毫秒，4.3%的患者QTc>60毫秒。在FLAURA2研究中，276例接受TAGRISSO联合培美曲塞和铂类化疗的患者中，1.8%的患者QTc>500毫秒，10.5%的患者QTc>60毫秒。

No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia.

没有QTc相关心律失常的报道。对先天性长QTc综合征、充血性心力衰竭、电解质异常或服用已知延长QTc间隔药物的患者进行心电图和电解质的定期监测。对于QTc间期延长并伴有危及生命的心律失常体征/症状的患者，永久停止使用TAGRISSO。

Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal.

在1813名接受塔格里索治疗的患者中，有3.8%发生了心肌病；0.1%的心肌病病例是致命的。在FLAURA2研究中，276例接受TAGRISSO联合培美曲塞和铂类化疗的患者中有9%发生心肌病；1.1%的心肌病病例致命。

A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%.

在1557名接受基线和至少一次随访LVEF评估的患者中，有4.2%的患者左心室射血分数（LVEF）从基线下降≥10%，LVEF降至＜50%。在ADAURA研究中，1.5%（5/325）的TAGRISSO治疗患者的LVEF从基线下降≥10%，下降至<50%。

In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to less than 50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment.

在FLAURA2研究中，8%（21/262）接受TAGRISSO联合培美曲塞和铂类化疗的患者，他们有基线和至少一次随访LVEF评估，LVEF下降≥10%，下降到50%以下。对于接受TAGRISSO单药治疗的患者，对有心脏危险因素的患者进行心脏监测，包括在基线和治疗期间评估LVEF。

For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO.

对于接受TAGRISSO联合培美曲塞和铂类化疗的患者，对所有患者进行心脏监测，包括在基线和治疗期间评估LVEF。评估治疗期间出现相关心脏体征或症状的患者的LVEF。对于有症状的充血性心力衰竭，永久停用TAGRISSO。

Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist

在临床试验中，1813例接受TAGRISSO单药治疗的患者中有0.6%报告有角膜炎。及时将有角膜炎迹象和症状（如眼部炎症、流泪、光敏、视力模糊、眼痛和/或红眼）的患者转诊给眼科医生

Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed

据报道，接受TAGRISSO治疗的患者出现了与多形性红斑（EMM），史蒂文斯-约翰逊综合征（SJS）和中毒性表皮坏死松解症（TEN）一致的上市后病例。如果怀疑有EMM、SJS或TEN，则扣留TAGRISSO，如果确认，则永久停用

Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation.

据报道，接受TAGRISSO治疗的患者出现了上市后皮肤血管炎病例，包括白细胞碎裂性血管炎，荨麻疹性血管炎和IgA血管炎。如果怀疑皮肤血管炎，请停止使用TAGRISSO，评估全身受累情况，并考虑皮肤科咨询。

If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity.

如果无法确定其他病因，请根据严重程度考虑永久停用TAGRISSO。

Aplastic anemia has been reported in patients treated with TAGRISSO in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor.

据报道，在临床试验（1813年的0.06%）和上市后接受TAGRISSO治疗的患者患有再生障碍性贫血。有些病例有致命的后果。告知患者再生障碍性贫血的体征和症状，包括但不限于新发或持续发烧，瘀伤，出血和苍白。

If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated.

如果怀疑再生障碍性贫血，停止服用TAGRISSO并获得血液学咨询。如果确诊再生障碍性贫血，则永久停用TAGRISSO。在开始TAGRISSO之前，定期在整个治疗过程中进行全血细胞计数，如果有指示，则更频繁地进行全血细胞计数。

Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose.

在开始TAGRISSO之前，验证具有生殖潜力的女性的妊娠状况。告知孕妇对胎儿的潜在风险。建议具有生殖潜力的女性在使用TAGRISSO治疗期间和最终剂量后6周内使用有效的避孕方法。建议有生殖潜力的女性伴侣的男性在服用最终剂量后的4个月内使用有效的避孕方法。

Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the final dose

由于塔格里索母乳喂养的婴儿可能会产生严重的不良反应，因此女性在接受塔格里索治疗期间和最终剂量后2周内不应进行母乳喂养

Most common (≥20%) adverse reactions, including laboratory abnormalities, were:

包括实验室异常在内的最常见（≥20%）不良反应为：

TAGRISSO monotherapy: leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, and fatigue

TAGRISSO单一疗法：白细胞减少症、淋巴细胞减少症、血小板减少症、贫血、腹泻、皮疹、肌肉骨骼疼痛、中性粒细胞减少症、指甲毒性、皮肤干燥、口腔炎和疲劳

TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine

TAGRISSO联合培美曲塞和铂类化疗：白细胞减少、血小板减少、中性粒细胞减少、淋巴细胞减少、皮疹、腹泻、口腔炎、指甲毒性、皮肤干燥和血肌酐升高

INDICATIONS

适应症

TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

根据FDA批准的测试，TAGRISSO被指示为成年非小细胞肺癌（NSCLC）患者肿瘤切除后的辅助治疗，这些患者的肿瘤具有表皮生长因子受体（EGFR）外显子19缺失或外显子21 L858R突变

TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

TAGRISSO适用于转移性非小细胞肺癌（NSCLC）成年患者的一线治疗，这些患者的肿瘤具有表皮生长因子受体（EGFR）外显子19缺失或外显子21 L858R突变，这是通过FDA批准的测试检测到的

TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

TAGRISSO与培美曲塞和铂类化疗联合使用，用于局部晚期或转移性非小细胞肺癌患者的一线治疗，这些患者的肿瘤具有表皮生长因子受体（EGFR）外显子19缺失或外显子21 L858R突变，如FDA批准的测试所检测到的。

TAGRISSO is indicated for the treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy

TAGRISSO用于治疗转移性表皮生长因子受体（EGFR）T790M突变阳性NSCLC的成年患者，这是通过FDA批准的测试检测到的，其疾病在EGFR酪氨酸激酶抑制剂（TKI）治疗时或之后进展

Please see complete Prescribing Information, including Patient Information for TAGRISSO.

请参阅完整的处方信息，包括TAGRISSO的患者信息。

IMPORTANT SAFETY INFORMATION FOR IMFINZI® (durvalumab)

IMFINZI的重要安全信息® （durvalumab）

There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).

IMFINZI没有禁忌症® （durvalumab）或IMJUDO® （特利单抗actl）。

Severe and Fatal Immune-Mediated Adverse Reactions

严重和致命的免疫介导的不良反应

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation.

警告和注意事项中列出的重要免疫介导的不良反应可能不包括所有可能的严重和致命的免疫介导反应。免疫介导的不良反应可能严重或致命，可能发生在任何器官系统或组织中。免疫介导的不良反应可能在开始治疗后或停药后的任何时间发生。

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection.

密切监测患者的症状和体征，这些症状和体征可能是潜在的免疫介导的不良反应的临床表现。在基线和每次给药前评估临床化学物质，包括肝酶，肌酐，促肾上腺皮质激素（ACTH）水平和甲状腺功能。在疑似免疫介导的不良反应的情况下，启动适当的检查以排除其他病因，包括感染。

Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less.

及时进行医疗管理，包括适当的专业咨询。根据严重程度，停止或永久停止IMFINZI和IMJUDO。有关具体细节，请参阅USPI剂量和给药。一般来说，如果IMFINZI和IMJUDO需要中断或停药，则给予全身皮质类固醇治疗（1 mg至2 mg/kg/天泼尼松或等效药物），直到改善至1级或更低。

Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy..

在改善至1级或更低级别后，开始逐渐减少皮质类固醇，并在至少1个月内继续逐渐减少。对于免疫介导的不良反应不能用皮质类固醇治疗控制的患者，考虑服用其他全身免疫抑制剂。。

Immune-Mediated Pneumonitis

免疫介导性肺炎

IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

IMFINZI和IMJUDO可引起免疫介导的肺炎，这可能是致命的。先前接受过胸部放疗的患者肺炎的发生率较高。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo.

在未接受近期放疗的患者中，免疫介导性肺炎的发生率为2.4%（34/1414），包括致命性（<0.1%）和3-4级（0.4%）不良反应。在最近接受过放射治疗的患者中，在太平洋地区IMFINZI开始前42天内，不可切除的III期非小细胞肺癌患者在接受IMFINZI治疗的患者中，肺炎（包括放射性肺炎）的发生率为18.3%（87/475），接受安慰剂的患者为12.8%（30/234）。

Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions..

在接受IMFINZI（475）的患者中，1.1%是致命的，2.7%是3级不良反应。。

The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.

在IMFINZI之前未接受明确放化疗的患者中，免疫介导性肺炎的发生频率和严重程度与接受IMFINZI作为单一药物或ES-SCLC或BTC联合化疗的患者相似。

IMFINZI with IMJUDO

IMJUDO设置

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有1.3%（5/388）发生免疫介导的肺炎，包括致命（0.3%）和3级（0.2%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有3.5%（21/596）发生免疫介导的肺炎，包括致命（0.5%）和3级（1%）不良反应。

Immune-Mediated Colitis

免疫介导的结肠炎

IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal.

IMFINZI联合IMJUDO和铂类化疗可引起免疫介导的结肠炎，这可能是致命的。

IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies..

IMFINZI和IMJUDO可引起免疫介导的结肠炎，这通常与腹泻有关。据报道，皮质类固醇难治性免疫介导性结肠炎患者的巨细胞病毒（CMV）感染/再激活。在皮质类固醇难治性结肠炎的情况下，考虑重复感染性检查以排除其他病因。。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.

接受IMFINZI治疗的患者中有2%（37/1889）发生免疫介导的结肠炎，包括4级（<0.1%）和3级（0.4%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO治疗的患者中有6%（23/388）发生免疫介导的结肠炎或腹泻，包括3级（3.6%）不良反应。在IMFINZI和IMJUDO的其他研究中也观察到了肠穿孔。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有6.5%（39/596）发生免疫介导的结肠炎，包括致命（0.2%）和3级（2.5%）不良反应。0.1%的患者报告有肠穿孔和大肠穿孔。

Immune-Mediated Hepatitis

免疫介导的肝炎

IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.

IMFINZI和IMJUDO可引起免疫介导的肝炎，这可能是致命的。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.

接受IMFINZI治疗的患者中有2.8%（52/1889）发生免疫介导的肝炎，包括致命（0.2%），4级（0.3%）和3级（1.4%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有7.5%（29/388）发生免疫介导的肝炎，包括致命（0.8%），4级（0.3%）和3级（4.1%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有3.9%（23/596）发生免疫介导的肝炎，包括致命（0.3%），4级（0.5%）和3级（2%）不良反应。

Immune-Mediated Endocrinopathies

免疫介导的内分泌病

Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.

肾上腺功能不全：IMFINZI和IMJUDO可引起原发性或继发性肾上腺功能不全。对于2级或更高级别的肾上腺功能不全，开始对症治疗，包括临床指示的激素替代。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

接受IMFINZI治疗的患者中有0.5%（9/1889）发生免疫介导的肾上腺功能不全，包括3级（<0.1%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有1.5%（6/388）发生免疫介导的肾上腺功能不全，包括3级（0.3%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有2.2%（13/596）发生免疫介导的肾上腺功能不全，包括3级（0.8%）不良反应。

Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated..

垂体炎：IMFINZI和IMJUDO可引起免疫介导的垂体炎。垂体炎可出现与肿块效应相关的急性症状，如头痛，畏光或视野割伤。垂体炎可引起垂体功能减退。开始对症治疗，包括临床指示的激素替代。。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.

接受IMFINZI治疗的患者中，3级垂体炎/垂体功能减退发生率低于0.1%（1/1889）。

IMFINZI with IMJUDO

IMJUDO设置

Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO的患者中有1%（4/388）发生了免疫介导的垂体炎/垂体功能减退症。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有1.3%（8/596）发生免疫介导的垂体炎，包括3级（0.5%）不良反应。

Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism): IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated..

甲状腺疾病（甲状腺炎，甲状腺功能亢进和甲状腺功能减退）：IMFINZI和IMJUDO可引起免疫介导的甲状腺疾病。甲状腺炎可伴有或不伴有内分泌病。甲状腺功能减退症可继发于甲状腺功能亢进症。根据临床指示，开始甲状腺功能减退症的激素替代疗法或甲状腺功能亢进症的医疗管理。。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

接受IMFINZI治疗的患者中有0.5%（9/1889）发生免疫介导的甲状腺炎，包括3级（<0.1%）不良反应。

Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.

接受IMFINZI的患者中有2.1%（39/1889）发生免疫介导的甲状腺功能亢进。

Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

接受IMFINZI治疗的患者中有8.3%（156/1889）发生免疫介导的甲状腺功能减退症，包括3级（<0.1%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO的患者中有1.5%（6/388）发生了免疫介导的甲状腺炎。

Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有4.6%（18/388）发生免疫介导的甲状腺功能亢进，包括3级（0.3%）不良反应。

Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO的患者中有11%（42/388）发生了免疫介导的甲状腺功能减退症。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.

接受IMFINZI联合IMJUDO和铂类化疗的患者中，有1.2%（7/596）发生了免疫介导的甲状腺炎。

Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有5%（30/596）发生免疫介导的甲状腺功能亢进，包括3级（0.2%）不良反应。

Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有8.6%（51/596）发生免疫介导的甲状腺功能减退症，包括3级（0.5%）不良反应。

Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.

1型糖尿病，可伴有糖尿病酮症酸中毒：监测患者的高血糖或其他糖尿病体征和症状。根据临床指示开始胰岛素治疗。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.

接受IMFINZI治疗的患者中，3级免疫介导的1型糖尿病发生率低于0.1%（1/1889）。

IMFINZI with IMJUDO

IMJUDO设置

Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.

两名患者（0.5%，2/388）发生高血糖事件，需要胰岛素治疗，但在最后一次随访中尚未解决。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.

0.5%（3/596）接受IMFINZI联合IMJUDO和铂类化疗的患者发生免疫介导的1型糖尿病，包括3级（0.3%）不良反应。

Immune-Mediated Nephritis with Renal Dysfunction

免疫介导性肾炎伴肾功能不全

IMFINZI and IMJUDO can cause immune-mediated nephritis.

IMFINZI和IMJUDO可引起免疫介导的肾炎。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

接受IMFINZI治疗的患者中有0.5%（10/1889）发生免疫介导的肾炎，包括3级（<0.1%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有1%（4/388）发生免疫介导的肾炎，包括3级（0.5%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中，有0.7%（4/596）发生免疫介导的肾炎，包括3级（0.2%）不良反应。

Immune-Mediated Dermatology Reactions

免疫介导的皮肤病反应

IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes..

IMFINZI和IMJUDO可引起免疫介导的皮疹或皮炎。PD-1/L-1和CTLA-4阻断抗体发生了剥脱性皮炎，包括史蒂文斯-约翰逊综合征（SJS），嗜酸性粒细胞增多和全身症状的药疹（DRESS）和中毒性表皮坏死松解症（TEN）。局部润肤剂和/或局部皮质类固醇可能足以治疗轻度至中度非剥脱性皮疹。。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.

接受IMFINZI治疗的患者中有1.8%（34/1889）发生免疫介导的皮疹或皮炎，包括3级（0.4%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

接受IMFINZI和IMJUDO治疗的患者中有4.9%（19/388）发生免疫介导的皮疹或皮炎，包括4级（0.3%）和3级（1.5%）不良反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有7.2%（43/596）发生免疫介导的皮疹或皮炎，包括3级（0.3%）不良反应。

Immune-Mediated Pancreatitis

免疫介导的胰腺炎

IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

IMFINZI联合IMJUDO可引起免疫介导的胰腺炎。接受IMFINZI和IMJUDO治疗的患者中有2.3%（9/388）发生免疫介导的胰腺炎，包括4级（0.3%）和3级（1.5%）不良反应。

Other Immune-Mediated Adverse Reactions

其他免疫介导的不良反应

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.

在接受IMFINZI和IMJUDO治疗或报告使用其他免疫检查点抑制剂的患者中，以下具有临床意义的免疫介导的不良反应发生率均低于1%。

Cardiac/vascular: Myocarditis, pericarditis, vasculitis.

心脏/血管：心肌炎，心包炎，血管炎。

Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.

神经系统：脑膜炎，脑炎，脊髓炎和脱髓鞘，肌无力综合征/重症肌无力（包括恶化），格林-巴利综合征，神经麻痹，自身免疫性神经病。

Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss..

眼部：可能发生葡萄膜炎，虹膜炎和其他眼部炎症毒性。有些病例可能与视网膜脱离有关。可能会出现各种程度的视力障碍，包括失明。如果葡萄膜炎与其他免疫介导的不良反应一起发生，请考虑Vogt-Koyanagi-Harada样综合征，因为这可能需要用全身类固醇治疗以降低永久性视力丧失的风险。。

Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.

胃肠道：胰腺炎包括血清淀粉酶和脂肪酶水平升高，胃炎，十二指肠炎。

Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.

肌肉骨骼和结缔组织疾病：肌炎/多发性肌炎，横纹肌溶解症和相关后遗症，包括肾衰竭，关节炎，风湿性多肌痛。

Endocrine: Hypoparathyroidism.

内分泌：甲状旁腺功能减退。

Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection..

其他（血液学/免疫）：溶血性贫血，再生障碍性贫血，吞噬性淋巴组织细胞增多症，全身炎症反应综合征，组织细胞坏死性淋巴结炎（菊池淋巴结炎），结节病，免疫性血小板减少症，实体器官移植排斥反应，其他移植（包括角膜移植）排斥反应。。

Infusion-Related Reactions

输液相关反应

IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details.

IMFINZI和IMJUDO可引起严重或危及生命的输液相关反应。监测输液相关反应的体征和症状。根据严重程度，中断、减慢IMFINZI和IMJUDO的速度或永久停止IMFINZI和IMJUDO。有关具体细节，请参阅USPI剂量和给药。

For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses..

对于1级或2级输注相关反应，考虑使用后续剂量的预用药。。

IMFINZI as a Single Agent

IMFINZI作为单一代理人

Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI的患者中有2.2%（42/1889）发生输注相关反应，包括3级（0.3%）不良反应。

IMFINZI with IMJUDO

IMJUDO设置

Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI and IMJUDO.

接受IMFINZI和IMJUDO的10名（2.6%）患者发生了输液相关反应。

IMFINZI with IMJUDO and Platinum-Based Chemotherapy

IMFINZI联合IMJUDO和铂类化疗

Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

接受IMFINZI联合IMJUDO和铂类化疗的患者中有2.9%（17/596）发生输注相关反应，包括3级（0.3%）不良反应。

Complications of Allogeneic HSCT after IMFINZI

IMFINZI术后异基因造血干细胞移植的并发症

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause).

在接受PD-1/L-1阻断抗体治疗之前或之后接受异基因造血干细胞移植（HSCT）的患者可能会发生致命和其他严重并发症。与移植相关的并发症包括超急性移植物抗宿主病（GVHD），急性GVHD，慢性GVHD，降低强度调理后的肝静脉闭塞性疾病（VOD）以及需要类固醇的发热综合征（无确定的感染原因）。

These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT..

尽管在PD-1/L-1阻断和同种异体HSCT之间进行了干预治疗，但仍可能发生这些并发症。密切关注患者的移植相关并发症证据，并及时干预。考虑在同种异体HSCT之前或之后用PD-1/L-1阻断抗体治疗的益处与风险。。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO..

根据它们的作用机制和动物研究数据，IMFINZI和IMJUDO在给孕妇服用时会造成胎儿伤害。告知孕妇对胎儿的潜在风险。对于具有生殖潜力的女性，在开始服用IMFINZI和IMJUDO之前，先验证其妊娠状况，并建议他们在服用IMFINZI和IMJUDO期间以及服用最后一剂IMFINZI和IMJUDO后3个月内使用有效的避孕措施。。

Lactation

哺乳期

There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.

没有关于母乳中存在IMFINZI和IMJUDO的信息；然而，由于IMFINZI和IMJUDO母乳喂养的婴儿可能会产生严重的不良反应，因此建议女性在治疗期间和最后一次给药后3个月内不要母乳喂养。

Adverse Reactions

不良反应

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%)..

在接受IMFINZI治疗的太平洋研究III期NSCLC患者中（n=475），最常见的不良反应（≥20%）是咳嗽（40%），疲劳（34%），肺炎或放射性肺炎（34%），上呼吸道感染（26%），呼吸困难（25%）和皮疹（23%）。最常见的3或4级不良反应（≥3%）是肺炎（7%）和肺炎/放射性肺炎（3.4%）。。

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%).

在接受IMFINZI（n=475）的太平洋研究中，III期NSCLC患者中，IMFINZI组15%的患者因不良反应而停药。29%接受IMFINZI治疗的患者发生严重不良反应。最常见的严重不良反应（≥2%）是肺炎或放射性肺炎（7%）和肺炎（6%）。

Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms..

小于2%的患者发生致命性肺炎或放射性肺炎和致命性肺炎，两组相似。。

In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%)..

在波塞冬研究中接受IMFINZI和IMJUDO加铂类化疗（n=330）的mNSCLC患者中，最常见的不良反应（发生率≥20%）是恶心（42%），疲劳（36%），肌肉骨骼疼痛（29%），食欲下降（28%），皮疹（27%）和腹泻（22%）。。

In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%).

在波塞冬研究中接受IMFINZI联合IMJUDO和铂类化疗（n=330）的mNSCLC患者中，17%的患者因不良反应而永久停用IMFINZI或IMJUDO。44%的患者发生严重不良反应，其中至少2%的患者报告最常见的严重不良反应为肺炎（11%），贫血（5%），腹泻（2.4%），血小板减少症（2.4%），发热（2.4%）和发热性中性粒细胞减少症（2.1%）。

Fatal adverse reactions occurred in a total of 4.2% of patients..

共有4.2%的患者发生致命的不良反应。。

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%).

在里海研究中接受IMFINZI加化疗（n=265）的广泛期SCLC患者中，最常见的不良反应（≥20%）是恶心（34%），疲劳/虚弱（32%）和脱发（31%）。最常见的3或4级不良反应（≥3%）是疲劳/虚弱（3.4%）。

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy.

在接受IMFINZI加化疗的里海研究中，广泛期SCLC患者（n=265）因7%接受IMFINZI加化疗的患者出现不良反应而停用IMFINZI。接受IMFINZI加化疗的患者中有31%发生严重不良反应。

The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy..

至少1%的患者报告的最常见的严重不良反应是发热性中性粒细胞减少症（4.5%），肺炎（2.3%），贫血（1.9%），全血细胞减少症（1.5%），肺炎（1.1%）和COPD（1.1%）。接受IMFINZI加化疗的患者中有4.9%发生致命的不良反应。。

In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).

在接受IMFINZI治疗的TOPAZ-1研究中，局部晚期或转移性BTC患者（n=338），最常见的不良反应（发生率≥20%）是疲劳（42%），恶心（40%），便秘（32%），食欲下降（26%），腹痛（24%），皮疹（23%）和发热（20%）。

In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%) and acute kidney injury (2.4%).

在接受IMFINZI（n=338）的TOPAZ-1研究中，局部晚期或转移性BTC患者中，6%接受IMFINZI加化疗的患者因不良反应而停药。47%接受IMFINZI联合化疗的患者发生严重不良反应。至少2%的患者报告的最常见的严重不良反应是胆管炎（7%），发热（3.8%），贫血（3.6%），败血症（3.3%）和急性肾损伤（2.4%）。

Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients)..

接受IMFINZI加化疗的患者中有3.6%发生致命的不良反应。其中包括缺血性或出血性中风（4例），败血症（2例）和上消化道出血（2例）。。

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).

在接受IMFINZI和IMJUDO（n=388）的喜马拉雅研究中，无法切除的HCC患者中，最常见的不良反应（发生率≥20%）是皮疹（32%），腹泻（27%），疲劳（26%），瘙痒（23%），肌肉骨骼疼痛（22%）和腹痛（20%）。

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%).

在接受IMFINZI和IMJUDO（n=388）的喜马拉雅研究中，无法切除的HCC患者中，41%的患者发生严重不良反应。>1%的患者出现严重不良反应，包括出血（6%），腹泻（4%），败血症（2.1%），肺炎（2.1%），皮疹（1.5%），呕吐（1.3%），急性肾损伤（1.3%）和贫血（1.3%）。

Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients..

接受IMFINZI和IMJUDO治疗的患者中有8%发生致命不良反应，包括死亡（1%），颅内出血（0.5%），心脏骤停（0.5%），肺炎（0.5%），肝衰竭（0.5%）和免疫介导的肝炎（0.5%）。14%的患者因不良反应而永久停止治疗方案。。

The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.

IMFINZI和IMJUDO的安全性和有效性尚未在儿科患者中确立。

Indications:

适应症：

IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

IMFINZI适用于治疗无法切除的III期非小细胞肺癌（NSCLC）的成年患者，这些患者在同时进行铂类化疗和放疗后疾病尚未进展。

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

IMFINZI联合IMJUDO和铂类化疗可用于治疗无致敏表皮生长因子受体（EGFR）突变或间变性淋巴瘤激酶（ALK）基因组肿瘤畸变的成年转移性NSCLC患者。

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

IMFINZI联合依托泊苷和卡铂或顺铂，适用于成人广泛期小细胞肺癌（ES-SCLC）患者的一线治疗。

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

IMFINZI与吉西他滨和顺铂联合用于治疗局部晚期或转移性胆道癌（BTC）的成年患者。

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

IMFINZI联合IMJUDO适用于治疗成人不可切除肝细胞癌（uHCC）。

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

请参阅完整的处方信息，包括IMFINZI和IMJUDO的药物指南。

IMPORTANT SAFETY INFORMATION FOR LYNPARZA® (olaparib)

LYNPARZA®（olaparib）的重要安全信息

CONTRAINDICATIONS

禁忌症

There are no contraindications for LYNPARZA.

LYNPARZA没有禁忌症。

WARNINGS AND PRECAUTIONS

警告和注意事项

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.2% of patients with various BRCAm, gBRCAm, HRR gene-mutated or HRD-positive cancers who received LYNPARZA as a single agent or as part of a combination regimen, consistent with the approved indications, and the majority of events had a fatal outcome.

骨髓增生异常综合征/急性髓细胞白血病（MDS/AML）：大约1.2%的患有各种BRCAm，gBRCAm，HRR基因突变或HRD阳性癌症的患者接受LYNPARZA作为单一药物或作为联合方案的一部分，符合批准的适应症，并且大多数事件具有致命的结果。

The median duration of therapy in patients who developed MDS/AML was approximately 2 years (range: <6 months to >4 years). All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy..

MDS/AML患者的中位治疗时间约为2年（范围：<6个月至>4年）。所有这些患者都曾接受过铂类药物和/或其他DNA损伤剂的化疗，包括放疗。。

In SOLO-1, patients with newly diagnosed advanced BRCAm ovarian cancer, the incidence of MDS/AML was 1.9% (5/260) in patients who received LYNPARZA and 0.8% (1/130) in patients who received placebo based on an updated analysis. In PAOLA-1, of patients with newly diagnosed advanced ovarian cancer with HRD-positive status, the incidence of MDS/AML was 1.6% (4/255) in patients who received LYNPARZA and 2.3% (3/131) in the control arm..

在SOLO-1中，新诊断的晚期BRCAm卵巢癌患者中，接受LYNPARZA治疗的患者MDS/AML发生率为1.9%（5/260），接受安慰剂治疗的患者MDS/AML发生率为0.8%（1/130）。在PAOLA-1中，在HRD阳性状态的新诊断晚期卵巢癌患者中，接受LYNPARZA治疗的患者MDS/AML发生率为1.6%（4/255），对照组为2.3%（3/131）。。

In SOLO-2, patients with BRCAm platinum-sensitive relapsed ovarian cancer, the incidence of MDS/AML was 8% (15/195) in patients who received LYNPARZA and 4% (4/99) in patients who received placebo. The duration of LYNPARZA treatment prior to the diagnosis of MDS/AML ranged from 0.6 years to 4.5 years..

在SOLO-2中，BRCAm铂敏感复发性卵巢癌患者中，接受LYNPARZA治疗的患者MDS/AML发生率为8%（15/195），接受安慰剂治疗的患者MDS/AML发生率为4%（4/99）。在诊断为MDS/AML之前，LYNPARZA治疗的持续时间为0.6年至4.5年。。

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery..

在患者从先前化疗引起的血液学毒性（≤1级）恢复之前，不要开始使用LYNPARZA。在基线时监测全血细胞计数的血细胞减少症，此后每月监测治疗期间的临床显着变化。对于长期的血液学毒性，中断LYNPARZA并每周监测血细胞计数直至恢复。。

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

如果4周后水平仍未恢复到1级或更低，请将患者转介给血液学家进行进一步检查，包括骨髓分析和细胞遗传学血液样本。如果MDS/AML得到确认，停止使用LYNPARZA。

Pneumonitis: Occurred in 0.8% of patients exposed to LYNPARZA monotherapy, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation.

肺炎：暴露于LYNPARZA单一疗法的患者中有0.8%发生肺炎，有些病例致命。如果患者出现新的或恶化的呼吸道症状，如呼吸困难，咳嗽和发烧，或出现放射学异常，请中断LYNPARZA治疗并立即进行调查。

Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately..

如果确诊肺炎，停止使用LYNPARZA，并对患者进行适当治疗。。

Venous Thromboembolism (VTE): Including severe or fatal pulmonary embolism (PE) occurred in patients treated with LYNPARZA. In the combined data of two randomized, placebo-controlled clinical studies (PROfound and PROpel) in patients with metastatic castration-resistant prostate cancer (N=1180), VTE occurred in 8% of patients who received LYNPARZA, including pulmonary embolism in 6%.

静脉血栓栓塞（VTE）：包括用LYNPARZA治疗的患者发生严重或致命的肺栓塞（PE）。在转移性去势抵抗性前列腺癌患者（N=1180）的两项随机，安慰剂对照临床研究（深刻和推进）的综合数据中，接受LYNPARZA治疗的患者中有8%发生VTE，其中肺栓塞发生率为6%。

In the control arms, VTE occurred in 2.5%, including pulmonary embolism in 1.5%. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated..

在对照组中，VTE发生率为2.5%，其中肺栓塞发生率为1.5%。监测患者静脉血栓形成和肺栓塞的体征和症状，并根据医学需要进行治疗，其中可能包括临床指示的长期抗凝治疗。。

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating treatment.

胚胎-胎儿毒性：根据其作用机制和在动物中的发现，LYNPARZA可引起胎儿伤害。在开始治疗之前，验证具有生殖潜力的女性的妊娠状况。

Females

女性

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

告知女性生殖潜力对胎儿的潜在风险，并在治疗期间和最后一次给药后6个月内使用有效的避孕措施。

Males

男性

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

建议有生殖潜能的女性伴侣或怀孕的男性患者在治疗期间和最后一剂LYNPARZA后3个月内使用有效的避孕方法，在此期间不要捐献精子。

ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

不良反应一线维持治疗BRCAm晚期卵巢癌

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary tract infection (13%), thrombocytopenia (11%), and stomatitis (11%)..

在SOLO-1一线维护环境中接受LYNPARZA治疗的患者中，≥10%的患者最常见的不良反应（1-4级）是：恶心（77%），疲劳（67%），腹痛（45%），呕吐（40%），贫血（38%），腹泻（37%），便秘（28%），上呼吸道感染/流感/鼻咽炎/支气管炎（28%），味觉障碍（26%），食欲下降（20%），头晕（20%），中性粒细胞减少（17%），消化不良（17%），呼吸困难（15%），白细胞减少（13%），尿路感染（13%），血小板减少（11%）和口腔炎（11%）。。

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%)..

在SOLO-1一线维护环境中接受LYNPARZA治疗的患者中，≥25%的患者最常见的实验室异常（1-4级）是：血红蛋白减少（87%），平均红细胞体积增加（87%），白细胞减少（70%），淋巴细胞减少（67%），绝对中性粒细胞计数减少（51%），血小板减少（35%），血清肌酐增加（34%）。。

ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

不良反应一线维持治疗晚期卵巢癌联合贝伐单抗

Most common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab and at a ≥5% frequency compared to placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%).

在PAOLA-1的一线维持治疗中，与安慰剂/贝伐单抗相比，接受LYNPARZA/贝伐单抗治疗的患者中≥10%的患者最常见的不良反应（1-4级）为：恶心（53%），疲劳（包括虚弱）（53%），贫血（41%），淋巴细胞减少（24%），呕吐（22%）和白细胞减少（18%）。

In addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%)..

此外，与安慰剂/贝伐单抗组相比，接受LYNPARZA/贝伐单抗治疗的患者最常见的不良反应（≥10%）是：腹泻（18%），中性粒细胞减少（18%），尿路感染（15%）和头痛（14%）。。

In addition, venous thromboembolism occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

此外，接受LYNPARZA/贝伐单抗治疗的患者（5%）比接受安慰剂/贝伐单抗治疗的患者（1.9%）更常发生静脉血栓栓塞。

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%)..

在PAOLA-1的一线维持治疗中，≥25%的LYNPARZA联合贝伐单抗患者最常见的实验室异常（1-4级）是：血红蛋白减少（79%），淋巴细胞减少（63%），血清肌酐增加（61%），白细胞减少（59%），绝对中性粒细胞计数减少（35%）和血小板减少（35%）。。

ADVERSE REACTIONS—Maintenance gBRCAm Recurrent Ovarian Cancer

不良反应维持gBRCAm复发性卵巢癌

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%)..

在SOLO-2维持治疗中接受LYNPARZA治疗的患者中，≥20%的患者最常见的不良反应（1-4级）是：恶心（76%），疲劳（包括虚弱）（66%），贫血（44%），呕吐（37%），鼻咽炎/上呼吸道感染（URI）/流感（36%），腹泻（33%），关节痛/肌痛（30%），味觉障碍（27%），头痛（26%），食欲下降（22%）和口腔炎（20%）。。

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: increase in mean corpuscular volume (89%), decrease in hemoglobin (83%), decrease in leukocytes (69%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), increase in serum creatinine (44%), and decrease in platelets (42%)..

在SOLO-2维持治疗中接受LYNPARZA治疗的患者中，≥25%的患者最常见的实验室异常（1-4级）是：平均红细胞体积增加（89%），血红蛋白减少（83%），白细胞减少（69%），淋巴细胞减少（67%），绝对中性粒细胞计数减少（51%），血清肌酐增加（44%）和血小板减少（42%）。。

ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

不良反应gBRCAm、HER2阴性、高危早期乳腺癌的辅助治疗

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: nausea (57%), fatigue (including asthenia) (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%)..

在奥林匹亚辅助治疗中接受LYNPARZA治疗的患者中，≥10%的患者最常见的不良反应（1-4级）是：恶心（57%），疲劳（包括虚弱）（42%），贫血（24%），呕吐（23%），头痛（20%），腹泻（18%），白细胞减少（17%），中性粒细胞减少（16%），食欲下降（13%），味觉障碍（12%），头晕（11%）和口腔炎（10%）。。

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: decrease in lymphocytes (77%), increase in mean corpuscular volume (67%), decrease in hemoglobin (65%), decrease in leukocytes (64%), and decrease in absolute neutrophil count (39%)..

在奥林匹亚辅助治疗中接受LYNPARZA治疗的患者中，≥25%的患者最常见的实验室异常（1-4级）是：淋巴细胞减少（77%），平均红细胞体积增加（67%），血红蛋白减少（65%），白细胞减少（64%），绝对中性粒细胞计数减少（39%）。。

ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast Cancer

不良反应gBRCAm，HER2阴性转移性乳腺癌

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%)..

在奥运会转移性环境中接受LYNPARZA治疗的患者中，≥20%的患者最常见的不良反应（1-4级）是：恶心（58%），贫血（40%），疲劳（包括虚弱）（37%），呕吐（30%），中性粒细胞减少症（27%），呼吸道感染（27%），白细胞减少症（25%），腹泻（21%）和头痛（20%）。。

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%)..

在奥运会转移性环境中接受LYNPARZA治疗的患者中，≥25%的患者最常见的实验室异常（1-4级）是：血红蛋白减少（82%），淋巴细胞减少（73%），白细胞减少（71%），平均红细胞体积增加（71%），绝对中性粒细胞计数减少（46%），血小板减少（33%）。。

ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

不良反应一线维持gBRCAm转移性胰腺癌

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%)..

在POLO一线维护环境中接受LYNPARZA治疗的患者中，≥10%的患者最常见的不良反应（1-4级）是：疲劳（60%），恶心（45%），腹痛（34%），腹泻（29%），贫血（27%），食欲下降（25%），便秘（23%），呕吐（20%），背痛（19%），关节痛（15%），皮疹（15%），血小板减少（14%），呼吸困难（13%），中性粒细胞减少（12%），鼻咽炎（12%），味觉障碍（11%）和口腔炎（10%）。。

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%)..

在POLO一线维护环境中接受LYNPARZA治疗的患者中，≥25%的患者最常见的实验室异常（1-4级）是：血清肌酐升高（99%），血红蛋白降低（86%），平均红细胞体积增加（71%），淋巴细胞减少（61%），血小板减少（56%），白细胞减少（50%），绝对中性粒细胞计数减少（25%）。。

ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

不良反应-HRR基因突变的转移性去势抵抗性前列腺癌

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

接受LYNPARZA治疗的患者中，≥10%的患者最常见的不良反应（1-4级）是：贫血（46%），疲劳（包括虚弱）（41%），恶心（41%），食欲下降（30%），腹泻（21%），呕吐（18%），血小板减少症（12%），咳嗽（11%）和呼吸困难（10%）。

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

接受LYNPARZA治疗的患者中，≥25%的患者最常见的实验室异常（1-4级）是：血红蛋白减少（98%），淋巴细胞减少（62%），白细胞减少（53%），绝对中性粒细胞减少计数（34%）。

ADVERSE REACTIONS—Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

不良反应转移性去势抵抗性前列腺癌联合阿比特龙和泼尼松或泼尼松龙

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA/abiraterone with a difference of ≥5% compared to placebo for PROpel were: anemia (48%), fatigue (including asthenia) (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia (14%), dizziness (14%), and abdominal pain (13%)..

接受LYNPARZA/阿比特龙治疗的患者中，≥10%的患者最常见的不良反应（1-4级）与安慰剂相比，差异≥5%，其中PROpel为：贫血（48%），疲劳（包括虚弱）（38%），恶心（30%），腹泻（19%），食欲下降（16%），淋巴细胞减少（14%），头晕（14%）和腹痛（13%）。。

Most common laboratory abnormalities (Grades 1-4) in ≥20% of patients who received LYNPARZA/abiraterone for PROpel were: decrease in hemoglobin (97%), decrease in lymphocytes (70%), decrease in platelets (23%), and decrease in absolute neutrophil count (23%).

接受LYNPARZA/阿比特龙治疗PROpel的患者中，≥20%的患者最常见的实验室异常（1-4级）是：血红蛋白减少（97%），淋巴细胞减少（70%），血小板减少（23%），绝对中性粒细胞计数减少（23%）。

DRUG INTERACTIONS

药物相互作用

Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

抗癌药物：LYNPARZA与其他骨髓抑制性抗癌药物（包括DNA损伤剂）的临床研究表明，骨髓抑制毒性增强和延长。

CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment..

CYP3A抑制剂：使用LYNPARZA时，避免共同服用强或中度CYP3A抑制剂。如果必须共同服用强效或中度CYP3A抑制剂，请减少LYNPARZA的剂量。建议患者在LYNPARZA治疗期间避免服用葡萄柚、葡萄柚汁、塞维利亚橙汁和塞维利亚橙汁。。

CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

CYP3A诱导剂：使用LYNPARZA时，避免共同服用强或中等CYP3A诱导剂。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose..

哺乳期：没有关于母乳中奥拉帕尼的存在及其对母乳喂养婴儿或产奶量的影响的数据。由于母乳喂养的婴儿可能会出现严重的不良反应，建议哺乳期妇女在接受LYNPARZA治疗期间和接受最终剂量后1个月内不要母乳喂养。。

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

儿科用途：LYNPARZA的安全性和有效性尚未在儿科患者中确定。

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

肝损伤：轻度或中度肝损伤患者（Child-Pugh A类和B类）不需要调整起始剂量。没有严重肝功能损害患者的数据（Child-Pugh C级）。

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min)..

肾功能损害：轻度肾功能损害患者（Cockcroft-Gault估计CLcr 51-80 mL/min）不建议调整剂量。对于中度肾功能不全（CLcr 31-50 mL/min）的患者，每天两次将LYNPARZA的剂量减少至200 mg。没有严重肾功能不全或终末期肾病（CLcr≤30 mL/min）患者的数据。。

INDICATIONS

适应症

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

LYNPARZA是一种聚（ADP-核糖）聚合酶（PARP）抑制剂，表明：

First-Line Maintenance BRCAm Advanced Ovarian Cancer

一线维护BRCAm晚期卵巢癌

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA..

用于维持治疗对一线铂类化疗完全或部分反应的有害或疑似有害种系或体细胞BRCA突变（gBRCAm或sBRCAm）晚期上皮性卵巢癌，输卵管癌或原发性腹膜癌的成年患者。根据FDA批准的LYNPARZA伴随诊断选择患者进行治疗。。

First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab

一线维持HRD阳性的晚期卵巢癌联合贝伐单抗

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:.

与贝伐单抗联合用于维持治疗晚期上皮性卵巢癌，输卵管癌或原发性腹膜癌的成年患者，这些患者对一线铂类化疗完全或部分有反应，并且其癌症与同源重组缺陷（HRD）相关，阳性状态由以下任一定义：。

a deleterious or suspected deleterious BRCA mutation, and/or

有害或疑似有害的BRCA突变，和/或

genomic instability

基因组不稳定性

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

根据FDA批准的LYNPARZA伴随诊断选择患者进行治疗。

Maintenance BRCA-mutated Recurrent Ovarian Cancer

维持BRCA突变的复发性卵巢癌

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA..

用于维持治疗对铂类化疗完全或部分反应的有害或疑似有害种系或体细胞BRCA突变（gBRCAm或sBRCAm）复发性上皮性卵巢癌，输卵管癌或原发性腹膜癌的成年患者。根据FDA批准的LYNPARZA伴随诊断选择患者进行治疗。。

Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

gBRCAm、HER2阴性、高危早期乳腺癌的辅助治疗

For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA..

用于辅助治疗已接受新辅助或辅助化疗的有害或疑似有害gBRCAm，人表皮生长因子受体2（HER2）阴性，高危早期乳腺癌的成年患者。根据FDA批准的LYNPARZA伴随诊断选择患者进行治疗。。

gBRCAm, HER2-Negative Metastatic Breast Cancer

gBRCAm，HER2阴性转移性乳腺癌

For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.

用于治疗在新辅助，辅助或转移环境中接受化疗的有害或疑似有害gBRCAm，人表皮生长因子受体2（HER2）阴性转移性乳腺癌的成年患者。激素受体（HR）阳性乳腺癌患者应事先接受内分泌治疗，或被认为不适合进行内分泌治疗。

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA..

根据FDA批准的LYNPARZA伴随诊断选择患者进行治疗。。

First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer

一线维持gBRCAm转移性胰腺癌

For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA..

用于维持治疗患有有害或疑似有害gBRCAm转移性胰腺癌的成年患者，其疾病在一线铂类化疗方案的至少16周内尚未进展。根据FDA批准的LYNPARZA伴随诊断选择患者进行治疗。。

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

HRR基因突变的转移性去势抵抗性前列腺癌

For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA..

用于治疗患有有害或疑似有害种系或体细胞同源重组修复（HRR）基因突变的转移性去势抵抗性前列腺癌（mCRPC）的成年患者，这些患者在先前用恩扎鲁胺或阿比特龙治疗后已取得进展。根据FDA批准的LYNPARZA伴随诊断选择患者进行治疗。。

BRCAm Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

BRCAm转移性去势抵抗性前列腺癌联合阿比特龙、泼尼松或泼尼松龙

In combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA..

联合阿比特龙和泼尼松龙或泼尼松龙（abi/pred）治疗有害或疑似有害BRCA突变（BRCAm）转移性去势抵抗性前列腺癌（mCRPC）的成年患者。根据FDA批准的LYNPARZA伴随诊断选择患者进行治疗。。

Please see complete Prescribing Information, including Medication Guide.

请参阅完整的处方信息，包括用药指南。

IMPORTANT SAFETY INFORMATION FOR ENHERTU® (fam-trastuzumab deruxtecan-nxki)

ENHERTU®（fam曲妥珠单抗deruxtecan nxki）的重要安全信息

Indications

适应症

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

ENHERTU是一种HER2定向抗体和拓扑异构酶抑制剂偶联物，用于治疗成年患者：

Unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either:

先前接受过抗HER2方案治疗的不可切除或转移性HER2阳性（IHC 3+或ISH阳性）乳腺癌：

– In the metastatic setting, or

–在转移性环境中，或

– In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy

–在新辅助或辅助治疗中，并在完成治疗后的六个月内或六个月内出现疾病复发

Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy

根据FDA批准的测试确定，不可切除或转移性HER2低（IHC 1+或IHC 2+/ISH-）乳腺癌，这些患者先前在转移性环境中接受过化疗，或者在完成辅助化疗后6个月内或6个月内出现疾病复发

Unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy

不可切除或转移的非小细胞肺癌（NSCLC），其肿瘤具有激活的HER2（ERBB2）突变，经FDA批准的测试检测，并且先前接受过全身治疗

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

根据客观反应率和反应持续时间，加速批准该适应症。继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。

Locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen

接受过曲妥珠单抗治疗的局部晚期或转移性HER2阳性（IHC 3+或IHC 2+/ISH阳性）胃或胃食管交界处（GEJ）腺癌

Unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options

先前接受过全身治疗且没有令人满意的替代治疗选择的不可切除或转移性HER2阳性（IHC3+）实体瘤

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

根据客观反应率和反应持续时间，加速批准该适应症。继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。

WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY

警告：间质性肺病和胚胎-胎儿毒性

Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis.

ENHERTU报道了间质性肺病（ILD）和肺炎，包括致命病例。监测并及时调查体征和症状，包括咳嗽、呼吸困难、发烧和其他新的或恶化的呼吸道症状。所有2级或更高ILD/肺炎患者永久停用ENHERTU。

Advise patients of the risk and to immediately report symptoms..

告知患者风险并立即报告症状。。

Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

怀孕期间接触ENHERTU会导致胚胎-胎儿伤害。告知患者这些风险以及有效避孕的必要性。

Contraindications

禁忌症

None.

没有。

Warnings and Precautions

警告和注意事项

Interstitial Lung Disease / Pneumonitis

间质性肺病/肺炎

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms.

用ENHERTU治疗的患者可能会发生严重，危及生命或致命的间质性肺病（ILD），包括肺炎。中度肾功能不全患者的1级和2级ILD/肺炎发生率较高。建议患者立即报告咳嗽、呼吸困难、发烧和/或任何新的或恶化的呼吸道症状。

Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose.

监测患者的ILD体征和症状。及时调查ILD的证据。通过放射成像评估疑似ILD的患者。考虑咨询肺科医生。对于无症状ILD/肺炎（1级），中断ENHERTU直至解决至0级，然后如果在发病日期≤28天内解决，则维持剂量。

If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks..

如果在发病日期后>28天内解决，则减少剂量一级。一旦怀疑ILD/肺炎（例如，≥0.5 mg/kg/天泼尼松龙或等效物），就考虑使用皮质类固醇治疗。对于有症状的ILD/肺炎（2级或更高），永久停用ENHERTU。一旦怀疑ILD/肺炎（例如，≥1 mg/kg/天泼尼松龙或同等药物），立即开始全身皮质类固醇治疗，并持续至少14天，然后逐渐减量至少4周。。

HER2-Positive or HER2-Low Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

HER2阳性或HER2低转移性乳腺癌，HER2突变NSCLC和实体瘤（包括IHC 3+）（5.4 mg/kg）

In patients with metastatic breast cancer, HER2-mutant NSCLC, and other solid tumors treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and/or pneumonitis occurred in 1.0% of patients treated with ENHERTU..

在用ENHERTU 5.4 mg/kg治疗的转移性乳腺癌，HER2突变型NSCLC和其他实体瘤患者中，ILD发生率为12%。首次发病的中位时间为5.5个月（范围：0.9至31.5）。1.0%接受ENHERTU治疗的患者因ILD和/或肺炎导致致命结局。。

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

HER2阳性的局部晚期或转移性胃癌（6.4 mg/kg）

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21).

在用ENHERTU 6.4 mg/kg治疗的局部晚期或转移性HER2阳性胃腺癌或GEJ腺癌患者中，ILD发生率为10%。首次发病的中位时间为2.8个月（范围：1.2至21）。

Neutropenia

中性粒细胞减少

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L), interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose.

用ENHERTU治疗的患者可能会出现严重的中性粒细胞减少症，包括发热性中性粒细胞减少症。在开始使用ENHERTU之前和每次给药之前以及根据临床指示监测全血细胞计数。对于3级中性粒细胞减少症（绝对中性粒细胞计数[ANC]<1.0至0.5 x 109/L），中断ENHERTU直至达到2级或更低，然后维持剂量。

For Grade 4 neutropenia (ANC <0.5 x 109/L), interrupt ENHERTU until resolved to Grade 2 or less, then reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by one level..

对于4级中性粒细胞减少症（ANC<0.5 x 109/L），中断ENHERTU直至达到2级或更低，然后将剂量减少一个水平。对于发热性中性粒细胞减少症（ANC<1.0 x 109/L，温度>38.3ºC或持续温度≥38ºC超过1小时），中断ENHERTU直至解决，然后将剂量减少一个水平。。

HER2-Positive or HER2-Low Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

HER2阳性或HER2低转移性乳腺癌，HER2突变NSCLC和实体瘤（包括IHC 3+）（5.4 mg/kg）

In patients with metastatic breast cancer, HER2-mutant NSCLC, and other solid tumors treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 63% of patients. Seventeen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 939).

在用ENHERTU 5.4 mg/kg治疗的转移性乳腺癌，HER2突变型NSCLC和其他实体瘤患者中，据报道63%的患者中性粒细胞计数下降。17%的患者中性粒细胞计数降低了3或4级。中性粒细胞计数首次下降的中位时间为22天（范围：2至939）。

Febrile neutropenia was reported in 1% of patients..

据报道，1%的患者出现发热性中性粒细胞减少症。。

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

HER2阳性的局部晚期或转移性胃癌（6.4 mg/kg）

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187).

在用ENHERTU 6.4 mg/kg治疗的局部晚期或转移性HER2阳性胃腺癌或GEJ腺癌患者中，据报道72%的患者中性粒细胞计数减少。51%的患者中性粒细胞计数降低了3或4级。中性粒细胞计数首次下降的中位时间为16天（范围：4至187）。

Febrile neutropenia was reported in 4.8% of patients..

据报道，4.8%的患者出现发热性中性粒细胞减少症。。

Left Ventricular Dysfunction

左心室功能不全

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated.

接受ENHERTU治疗的患者发生左心室功能障碍的风险可能会增加。用抗HER2疗法（包括ENHERTU）观察到左心室射血分数（LVEF）降低。根据临床指示，在开始ENHERTU之前和治疗期间定期评估LVEF。

Manage LVEF decrease through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks.

通过治疗中断管理LVEF降低。当LVEF>45%且从基线绝对下降10-20%时，继续用ENHERTU治疗。当LVEF为40-45%且从基线绝对下降小于10%时，继续使用ENHERTU治疗并在3周内重复LVEF评估。当LVEF为40-45%且从基线绝对下降为10-20%时，中断ENHERTU并在3周内重复LVEF评估。

If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks.

如果LVEF尚未从基线恢复到10%以内，则永久停用ENHERTU。如果LVEF从基线恢复到10%以内，则以相同剂量恢复用ENHERTU治疗。当LVEF小于40%或从基线绝对下降>20%时，中断ENHERTU并在3周内重复LVEF评估。

If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment..

如果LVEF小于40%或从基线绝对下降>20%，则永久停用ENHERTU。症状性充血性心力衰竭患者永久停用ENHERTU。在开始治疗之前，尚未对有临床显着心脏病史或LVEF<50%的患者进行ENHERTU治疗的研究。。

HER2-Positive or HER2-Low Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

HER2阳性或HER2低转移性乳腺癌，HER2突变NSCLC和实体瘤（包括IHC 3+）（5.4 mg/kg）

In patients with metastatic breast cancer, HER2-mutant NSCLC, and other solid tumors treated with ENHERTU 5.4 mg/kg, LVEF decrease was reported in 3.8% of patients, of which 0.6% were Grade 3.

在用ENHERTU 5.4 mg/kg治疗的转移性乳腺癌，HER2突变型NSCLC和其他实体瘤患者中，据报道3.8%的患者LVEF降低，其中0.6%为3级。

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

HER2阳性的局部晚期或转移性胃癌（6.4 mg/kg）

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF.

在用ENHERTU 6.4 mg/kg治疗的局部晚期或转移性HER2阳性胃腺癌或GEJ腺癌患者中，未报告心力衰竭的临床不良事件；然而，在超声心动图上，发现8%的LVEF无症状2级下降。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose of ENHERTU.

给孕妇服用恩贺图会对胎儿造成伤害。告知患者胎儿的潜在风险。在ENHERTU开始之前，验证具有生殖潜力的女性的妊娠状况。建议有生殖潜力的女性在治疗期间和最后一剂ENHERTU后7个月内使用有效的避孕措施。

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose of ENHERTU..

建议有生殖潜力的女性伴侣的男性患者在使用ENHERTU治疗期间和最后一剂ENHERTU后4个月内使用有效的避孕措施。。

Additional Dose Modifications

额外剂量修改

Thrombocytopenia

血小板减少症

For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then reduce dose by one level.

对于3级血小板减少症（血小板<50至25 x 109/L），中断ENHERTU直至达到1级或更低，然后维持剂量。对于4级血小板减少症（血小板<25 x 109/L），中断ENHERTU直至达到1级或更低，然后将剂量减少一个水平。

Adverse Reactions

不良反应

HER2-Positive and HER2-Low Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg)

HER2阳性和HER2低转移性乳腺癌，HER2突变NSCLC和实体瘤（包括IHC 3+）（5.4 mg/kg）

The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg intravenously every 3 weeks in 1799 patients in Study DS8201-A-J101 (NCT02564900), DESTINY-Breast01, DESTINY-Breast02, DESTINY-Breast03, DESTINY-Breast04, DESTINY-Lung01, DESTINY-Lung02, DESTINY-CRC02, and DESTINY-PanTumor02. Among these patients, 65% were exposed for >6 months and 38% were exposed for >1 year.

汇总的安全人群反映了研究DS8201-A-J101（NCT02564900），DESTINY-Breast01，DESTINY-Breast02，DESTINY-Breast03，DESTINY-Breast04，DESTINY-Lung01，DESTINY-Lung02，DESTINY-CRC02和DESTINY-PanTumor02中1799名患者每3周静脉注射5.4 mg/kg。在这些患者中，65%暴露于>6个月，38%暴露于>1年。

In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (73%), decreased white blood cell count (70%), decreased hemoglobin (66%), decreased neutrophil count (63%), decreased lymphocyte count (58%), fatigue (56%), decreased platelet count (48%), increased aspartate aminotransferase (47%), increased alanine aminotransferase (43%), vomiting (40%), increased blood alkaline phosphatase (38%), alopecia (34%), constipation (33%), decreased appetite (32%), decreased blood potassium (31%), diarrhea (29%), musculoskeletal pain (24%), and abdominal pain (20%)..

在这个汇总的安全人群中，包括实验室异常在内的最常见（≥20%）的不良反应是恶心（73%），白细胞计数减少（70%），血红蛋白减少（66%），中性粒细胞计数减少（63%），淋巴细胞计数减少（58%），疲劳（56%），血小板计数减少（48%），天冬氨酸转氨酶增加（47%），丙氨酸转氨酶增加（43%），呕吐（40%），血液碱性磷酸酶增加（38%），脱发（34%），便秘（33%），食欲下降（32%），血钾减少（31%），腹泻（29%），肌肉骨骼疼痛（24%）和腹痛（20%）。。

HER2-Positive Metastatic Breast Cancer

HER2阳性转移性乳腺癌

DESTINY-Breast03

DESTINY-Breast03

The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg intravenously once every three weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30).

在257例不可切除或转移性HER2阳性乳腺癌患者中评估了ENHERTU的安全性，这些患者在DESTINY-Breast03中每三周静脉注射至少一剂5.4 mg/kg的ENHERTU。中位治疗时间为14个月（范围：0.7至30）。

Serious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were vomiting, interstitial lung disease, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (one patient each)..

接受ENHERTU治疗的患者中有19%发生严重不良反应。接受ENHERTU治疗的患者中，>1%的严重不良反应是呕吐，间质性肺病，肺炎，发热和尿路感染。0.8%的患者因不良反应死亡，包括新型冠状病毒肺炎和猝死（各一名患者）。。

ENHERTU was permanently discontinued in 14% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD/pneumonitis.

14%的患者永久停用ENHERTU，其中ILD/肺炎占8%。44%接受ENHERTU治疗的患者因不良反应而发生剂量中断。与剂量中断相关的最常见不良反应（>2%）是中性粒细胞减少症，白细胞减少症，贫血，血小板减少症，肺炎，恶心，疲劳和ILD/肺炎。

Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, neutropenia, and fatigue..

21%接受ENHERTU治疗的患者剂量减少。与剂量减少相关的最常见不良反应（>2%）是恶心，中性粒细胞减少和疲劳。。

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (74%), decreased neutrophil count (70%), increased aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte count (55%), increased alanine aminotransferase (53%), decreased platelet count (52%), fatigue (49%), vomiting (49%), increased blood alkaline phosphatase (49%), alopecia (37%), decreased blood potassium (35%), constipation (34%), musculoskeletal pain (31%), diarrhea (29%), decreased appetite (29%), headache (22%), respiratory infection (22%), abdominal pain (21%), increased blood bilirubin (20%), and stomatitis (20%)..

最常见的（≥20%）不良反应包括实验室异常，包括恶心（76%），白细胞计数减少（74%），中性粒细胞计数减少（70%），天冬氨酸转氨酶增加（67%），血红蛋白减少（64%），淋巴细胞计数减少（55%），丙氨酸转氨酶增加（53%），血小板计数减少（52%），疲劳（49%），呕吐（49%），血液碱性磷酸酶增加（49%），脱发（37%），血钾减少（35%），便秘（34%），肌肉骨骼疼痛（31%），腹泻（29%），食欲下降（29%），头痛（22%），呼吸道感染（22%），腹痛（21%），血胆红素增加（20%）和口腔炎（20%）。。

HER2-Low Metastatic Breast Cancer

HER2低转移性乳腺癌

DESTINY-Breast04

DESTINY-Breast04

The safety of ENHERTU was evaluated in 371 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast04. The median duration of treatment was 8 months (range: 0.2 to 33) for patients who received ENHERTU..

对371例不可切除或转移性HER2低（IHC 1+或IHC 2+/ISH-）乳腺癌患者进行了ENHERTU的安全性评估，这些患者在DESTINY-Breast04中每3周静脉注射ENHERTU 5.4 mg/kg。接受ENHERTU治疗的患者的中位治疗时间为8个月（范围：0.2至33）。。

Serious adverse reactions occurred in 28% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, pneumonia, dyspnea, musculoskeletal pain, sepsis, anemia, febrile neutropenia, hypercalcemia, nausea, pyrexia, and vomiting. Fatalities due to adverse reactions occurred in 4% of patients including ILD/pneumonitis (3 patients); sepsis (2 patients); and ischemic colitis, disseminated intravascular coagulation, dyspnea, febrile neutropenia, general physical health deterioration, pleural effusion, and respiratory failure (1 patient each)..

接受ENHERTU治疗的患者中有28%发生严重不良反应。接受ENHERTU治疗的患者中，>1%的严重不良反应是ILD/肺炎，肺炎，呼吸困难，肌肉骨骼疼痛，败血症，贫血，发热性中性粒细胞减少症，高钙血症，恶心，发热和呕吐。包括ILD/肺炎（3例）在内的4%患者因不良反应死亡；败血症（2例）；和缺血性结肠炎，弥散性血管内凝血，呼吸困难，发热性中性粒细胞减少症，一般身体健康恶化，胸腔积液和呼吸衰竭（各1例）。。

ENHERTU was permanently discontinued in 16% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 39% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, fatigue, anemia, leukopenia, COVID-19, ILD/pneumonitis, increased transaminases, and hyperbilirubinemia.

16%的患者永久停用ENHERTU，其中ILD/肺炎占8%。39%接受ENHERTU治疗的患者因不良反应而发生剂量中断。与剂量中断相关的最常见不良反应（>2%）是中性粒细胞减少症，疲劳，贫血，白细胞减少症，COVID-19，ILD/肺炎，转氨酶升高和高胆红素血症。

Dose reductions occurred in 23% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, thrombocytopenia, and neutropenia..

23%接受ENHERTU治疗的患者剂量减少。与剂量减少相关的最常见不良反应（>2%）是疲劳，恶心，血小板减少和中性粒细胞减少。。

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (70%), decreased hemoglobin (64%), decreased neutrophil count (64%), decreased lymphocyte count (55%), fatigue (54%), decreased platelet count (44%), alopecia (40%), vomiting (40%), increased aspartate aminotransferase (38%), increased alanine aminotransferase (36%), constipation (34%), increased blood alkaline phosphatase (34%), decreased appetite (32%), musculoskeletal pain (32%), diarrhea (27%), and decreased blood potassium (25%)..

最常见的（≥20%）不良反应包括实验室异常，包括恶心（76%），白细胞计数减少（70%），血红蛋白减少（64%），中性粒细胞计数减少（64%），淋巴细胞计数减少（55%），疲劳（54%），血小板计数减少（44%），脱发（40%），呕吐（40%），天冬氨酸转氨酶增加（38%），丙氨酸转氨酶增加（36%），便秘（34%），血液碱性磷酸酶增加（34%），食欲下降（32%），肌肉骨骼疼痛（32%），腹泻（27%）和血钾减少（25%）。。

HER2-Mutant Unresectable or Metastatic NSCLC (5.4 mg/kg)

HER2突变不可切除或转移性NSCLC（5.4 mg/kg）

DESTINY-Lung02 evaluated two dose levels (5.4 mg/kg [n=101] and 6.4 mg/kg [n=50]); however, only the results for the recommended dose of 5.4 mg/kg intravenously every 3 weeks are described below due to increased toxicity observed with the higher dose in patients with NSCLC, including ILD/pneumonitis..

DESTINY-Lung02评估了两种剂量水平（5.4 mg/kg[n=101]和6.4 mg/kg[n=50]）；然而，由于在NSCLC患者（包括ILD/肺炎）中观察到较高剂量的毒性增加，因此每3周静脉注射推荐剂量5.4 mg/kg的结果如下所述。。

The safety of ENHERTU was evaluated in 101 patients with HER2-mutant unresectable or metastatic NSCLC who received ENHERTU 5.4 mg/kg intravenously once every three weeks until disease progression or unacceptable toxicity in DESTINY‑Lung02. Nineteen percent of patients were exposed for >6 months.

对101例HER2突变不可切除或转移性NSCLC患者进行了ENHERTU的安全性评估，这些患者每三周静脉注射一次ENHERTU 5.4 mg/kg，直至疾病进展或DESTINY-Lung02出现不可接受的毒性。19%的患者暴露时间超过6个月。

Serious adverse reactions occurred in 30% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, thrombocytopenia, dyspnea, nausea, pleural effusion, and increased troponin I. Fatality occurred in 1 patient with suspected ILD/pneumonitis (1%)..

接受ENHERTU治疗的患者中有30%发生严重不良反应。接受ENHERTU治疗的患者中，>1%的严重不良反应为ILD/肺炎，血小板减少，呼吸困难，恶心，胸腔积液和肌钙蛋白I升高。1例疑似ILD/肺炎患者（1%）死亡。。

ENHERTU was permanently discontinued in 8% of patients. Adverse reactions which resulted in permanent discontinuation of ENHERTU were ILD/pneumonitis, diarrhea, decreased blood potassium, hypomagnesemia, myocarditis, and vomiting. Dose interruptions of ENHERTU due to adverse reactions occurred in 23% of patients.

8%的患者永久停用ENHERTU。导致永久停用ENHERTU的不良反应是ILD/肺炎，腹泻，血钾降低，低镁血症，心肌炎和呕吐。23%的患者因不良反应而中断了ENHERTU的剂量。

Adverse reactions which required dose interruption (>2%) included neutropenia and ILD/pneumonitis. Dose reductions due to an adverse reaction occurred in 11% of patients..

需要中断剂量（>2%）的不良反应包括中性粒细胞减少症和ILD/肺炎。11%的患者因不良反应而减少剂量。。

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (61%), decreased white blood cell count (60%), decreased hemoglobin (58%), decreased neutrophil count (52%), decreased lymphocyte count (43%), decreased platelet count (40%), decreased albumin (39%), increased aspartate aminotransferase (35%), increased alanine aminotransferase (34%), fatigue (32%), constipation (31%), decreased appetite (30%), vomiting (26%), increased alkaline phosphatase (22%), and alopecia (21%)..

最常见的（≥20%）不良反应，包括实验室异常，是恶心（61%），白细胞计数减少（60%），血红蛋白减少（58%），中性粒细胞计数减少（52%），淋巴细胞计数减少（43%），血小板计数减少（40%），白蛋白减少（39%），天冬氨酸转氨酶增加（35%），丙氨酸转氨酶增加（34%），疲劳（32%），便秘（31%），食欲下降（30%），呕吐（26%），碱性磷酸酶增加（22%）和脱发（21%）。。

HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

HER2阳性的局部晚期或转移性胃癌（6.4 mg/kg）

The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01. Patients intravenously received at least one dose of either ENHERTU (N=125) 6.4 mg/kg every 3 weeks or either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks.

在DESTINY-Gastric01中，对187例局部晚期或转移性HER2阳性胃腺癌或GEJ腺癌患者评估了ENHERTU的安全性。患者每3周静脉注射至少一剂ENHERTU（N=125）6.4 mg/kg或伊立替康（N=55）150 mg/m2，每两周或紫杉醇（N=7）80 mg/m2，持续3周。

The median duration of treatment was 4.6 months (range: 0.7 to 22.3) for patients who received ENHERTU..

接受ENHERTU治疗的患者的中位治疗时间为4.6个月（范围：0.7至22.3）。。

Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in one patient each (0.8%)..

接受ENHERTU 6.4 mg/kg治疗的患者中有44%发生严重不良反应。>2%接受ENHERTU治疗的患者的严重不良反应是食欲下降，ILD，贫血，脱水，肺炎，胆汁淤积性黄疸，发热和肿瘤出血。2.4%的患者因不良反应死亡：弥散性血管内凝血、大肠穿孔和肺炎各发生1例（0.8%）。。

ENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and decreased blood potassium.

15%的患者永久停用ENHERTU，其中ILD占6%。62%接受ENHERTU治疗的患者因不良反应而发生剂量中断。与剂量中断相关的最常见不良反应（>2%）是中性粒细胞减少症，贫血，食欲下降，白细胞减少症，疲劳，血小板减少症，ILD，肺炎，淋巴细胞减少症，上呼吸道感染，腹泻和血钾降低。

Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia..

32%接受ENHERTU治疗的患者剂量减少。与剂量减少相关的最常见不良反应（>2%）是中性粒细胞减少症，食欲下降，疲劳，恶心和发热性中性粒细胞减少症。。

The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (75%), decreased white blood cell count (74%), decreased neutrophil count (72%), decreased lymphocyte count (70%), decreased platelet count (68%), nausea (63%), decreased appetite (60%), increased aspartate aminotransferase (58%), fatigue (55%), increased blood alkaline phosphatase (54%), increased alanine aminotransferase (47%), diarrhea (32%), decreased blood potassium (30%), vomiting (26%), constipation (24%), increased blood bilirubin (24%), pyrexia (24%), and alopecia (22%)..

包括实验室异常在内的最常见（≥20%）不良反应是血红蛋白降低（75%），白细胞计数降低（74%），中性粒细胞计数降低（72%），淋巴细胞计数降低（70%），血小板计数降低（68%），恶心（63%），食欲下降（60%），天冬氨酸转氨酶升高（58%），疲劳（55%），血液碱性磷酸酶升高（54%），丙氨酸转氨酶升高（47%），腹泻（32%），血钾降低（30%），呕吐（26%），便秘（24%），血胆红素升高（24%），发热（24%）和脱发（22%）。。

HER2-Positive (IHC3+) Unresectable or Metastatic Solid Tumors

HER2阳性（IHC3+）不可切除或转移性实体瘤

The safety of ENHERTU was evaluated in 347 adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast01, DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. The median duration of treatment was 8.3 months (range 0.7 to 30.2)..

在347例不可切除或转移性HER2阳性（IHC3+）实体瘤的成年患者中评估了ENHERTU的安全性，这些患者每3周在DESTINY-Breast01，DESTINY-PanTumor02，DESTINY-Lung01和DESTINY-CRC02中静脉注射ENHERTU 5.4 mg/kg。中位治疗时间为8.3个月（范围0.7至30.2）。。

Serious adverse reactions occurred in 34% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were sepsis, pneumonia, vomiting, urinary tract infection, abdominal pain, nausea, pneumonitis, pleural effusion, hemorrhage, COVID-19, fatigue, acute kidney injury, anemia, cellulitis, and dyspnea.

34%接受ENHERTU治疗的患者发生严重不良反应。接受ENHERTU治疗的患者中，>1%的严重不良反应为败血症，肺炎，呕吐，尿路感染，腹痛，恶心，肺炎，胸腔积液，出血，新型冠状病毒，疲劳，急性肾损伤，贫血，蜂窝织炎和呼吸困难。

Fatalities due to adverse reactions occurred in 6.3% of patients including ILD/pneumonitis (2.3%), cardiac arrest (0.6%), COVID-19 (0.6%), and sepsis (0.6%). The following events occurred in one patient each (0.3%): acute kidney injury, cerebrovascular accident, general physical health deterioration, pneumonia, and hemorrhagic shock..

6.3%的患者因不良反应死亡，包括ILD/肺炎（2.3%），心脏骤停（0.6%），新型冠状病毒肺炎（0.6%）和败血症（0.6%）。以下事件发生在每位患者中（0.3%）：急性肾损伤，脑血管意外，一般身体健康恶化，肺炎和失血性休克。。

ENHERTU was permanently discontinued in 15% of patients, of which ILD/pneumonitis accounted for 10%. Dose interruptions due to adverse reactions occurred in 48% of patients. The most frequent adverse reactions (>2%) associated with dose interruption were decreased neutrophil count, anemia, COVID-19, fatigue, decreased white blood cell count, and ILD/pneumonitis.

15%的患者永久停用ENHERTU，其中ILD/肺炎占10%。48%的患者因不良反应而中断剂量。与剂量中断相关的最常见不良反应（>2%）是中性粒细胞计数减少，贫血，新型冠状病毒肺炎，疲劳，白细胞计数减少和ILD/肺炎。

Dose reductions occurred in 27% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, decreased neutrophil count, ILD/pneumonitis, and diarrhea..

用ENHERTU治疗的患者中有27%发生剂量减少。与剂量减少相关的最常见不良反应（>2%）是疲劳，恶心，中性粒细胞计数减少，ILD/肺炎和腹泻。。

The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (75%), nausea (69%), decreased hemoglobin (67%), decreased neutrophil count (66%), fatigue (59%), decreased lymphocyte count (58%), decreased platelet count (51%), increased aspartate aminotransferase (45%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (36%), vomiting (35%), decreased appetite (34%), alopecia (34%), diarrhea (31%), decreased blood potassium (29%), constipation (28%), decreased sodium (22%), stomatitis (20%), and upper respiratory tract infection (20%)..

包括实验室异常在内的最常见（≥20%）的不良反应是白细胞计数减少（75%），恶心（69%），血红蛋白减少（67%），中性粒细胞计数减少（66%），疲劳（59%），淋巴细胞计数减少（58%），血小板计数减少（51%），天冬氨酸转氨酶增加（45%），丙氨酸转氨酶增加（44%），血液碱性磷酸酶增加（36%），呕吐（35%），食欲下降（34%），脱发（34%），腹泻（31%），血钾减少（29%），便秘（28%），钠减少（22%），口腔炎（20%）和上呼吸道感染（20%）。。

Use in Specific Populations

在特定人群中使用

Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months after the last dose of ENHERTU.

怀孕：恩贺图给孕妇服用时会对胎儿造成伤害。告知患者胎儿的潜在风险。如果孕妇使用ENHERTU，或者患者在最后一剂ENHERTU后7个月内怀孕，则有临床考虑。

Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose..

哺乳期：没有关于母乳中ENHERTU的存在，对母乳喂养的孩子的影响或对产奶量的影响的数据。由于母乳喂养的孩子可能会出现严重的不良反应，建议女性在使用ENHERTU治疗期间以及最后一次服用后7个月内不要母乳喂养。。

Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for 7 months after the last dose.

生殖潜能的女性和男性：妊娠测试：在开始ENHERTU之前验证生殖潜能女性的妊娠状况。避孕方法：女性：ENHERTU给孕妇服用时会对胎儿造成伤害。建议有生殖潜力的女性在使用ENHERTU治疗期间和最后一剂后7个月内使用有效的避孕方法。

Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose. Infertility: ENHERTU may impair male reproductive function and fertility..

男性：建议有生殖潜力的女性伴侣的男性患者在使用ENHERTU治疗期间和最后一剂后4个月内使用有效的避孕方法。不育症：ENHERTU可能会损害男性的生殖功能和生育能力。。

Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.

儿科使用：ENHERTU的安全性和有效性尚未在儿科患者中确定。

Geriatric Use: Of the 1287 patients with HER2-positive or HER2-low breast cancer treated with ENHERTU 5.4 mg/kg, 22% were ≥65 years and 3.8% were ≥75 years. No overall differences in efficacy within clinical studies were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (59%) as compared to younger patients (49%).

老年使用：在用ENHERTU 5.4 mg/kg治疗的1287例HER2阳性或HER2低乳腺癌患者中，22%的患者≥65岁，3.8%的患者≥75岁。与年轻患者相比，≥65岁的患者在临床研究中没有观察到总体疗效差异。与年轻患者（49%）相比，≥65岁患者（59%）观察到的3-4级不良反应发生率更高。

Of the 101 patients with HER2-mutant unresectable or metastatic NSCLC treated with ENHERTU 5.4 mg/kg, 40% were ≥65 years and 8% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. Of the 125 patients with HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg in DESTINY-Gastric01, 56% were ≥65 years and 14% were ≥75 years.

在用ENHERTU 5.4 mg/kg治疗的101例HER2突变不可切除或转移性NSCLC患者中，40%的患者≥65岁，8%的患者≥75岁。与年轻患者相比，≥65岁的患者在疗效或安全性方面没有观察到总体差异。在DESTINY-Gastric01中用ENHERTU 6.4 mg/kg治疗的125例HER2阳性局部晚期或转移性胃腺癌或GEJ腺癌患者中，56%≥65岁，14%≥75岁。

No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. Of the 192 patients with HER2-positive (IHC 3+) unresectable or metastatic solid tumors treated with ENHERTU 5.4 mg/kg in DESTINY-PanTumor02, DESTINY-Lung01, or DESTINY-CRC02, 39% were 65 years or older and 9% were 75 years or older.

与年轻患者相比，≥65岁的患者在疗效或安全性方面没有观察到总体差异。在DESTINY-PanTumor02，DESTINY-Lung01或DESTINY-CRC02中，用ENHERTU 5.4 mg/kg治疗的192例HER2阳性（IHC 3+）不可切除或转移性实体瘤患者中，39%为65岁或以上，9%为75岁或以上。

No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients..

与年轻患者相比，≥65岁的患者在疗效或安全性方面没有总体差异。。

Renal Impairment: A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Monitor patients with moderate renal impairment more frequently. The recommended dosage of ENHERTU has not been established for patients with severe renal impairment (CLcr <30 mL/min)..

肾功能损害：中度肾功能损害患者的1级和2级ILD/肺炎发生率较高。更频繁地监测中度肾功能不全患者。对于严重肾功能不全（CLcr<30 mL/min）的患者，尚未确定ENHERTU的推荐剂量。。

Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor, DXd. The recommended dosage of ENHERTU has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST)..

肝损伤：对于中度肝损伤患者，由于可能增加暴露，密切监测与拓扑异构酶抑制剂DXd相关的毒性增加。对于严重肝功能损害（总胆红素>3倍ULN和任何AST）的患者，尚未确定ENHERTU的推荐剂量。。

To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

要报告疑似不良反应，请联系Daiichi Sankyo，Inc.，电话1-877-437-7763或FDA，电话1-800-FDA-1088或FDA.gov/medwatch。

Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

请参阅随附的完整处方信息，包括盒装警告和药物指南。

Notes

注释

AstraZeneca in oncology

阿斯利康肿瘤学

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

阿斯利康（AstraZeneca）正在领导一场肿瘤学革命，致力于为各种形式的癌症提供治疗，遵循科学理解癌症及其复杂性，发现、开发并向患者提供改变生命的药物。

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

该公司专注于一些最具挑战性的癌症。正是通过不断的创新，阿斯利康建立了行业内最多样化的投资组合和渠道之一，有可能催化医学实践的变化并改变患者的体验。

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

阿斯利康的愿景是重新定义癌症护理，并有一天消除癌症作为死亡原因。

About AstraZeneca

关于阿斯利康

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.

阿斯利康是一家以科学为主导的全球生物制药公司，专注于肿瘤学、罕见病和生物制药（包括心血管、肾脏和代谢以及呼吸和免疫学）处方药的发现、开发和商业化。阿斯利康总部位于英国剑桥，在100多个国家开展业务，其创新药物被全球数百万患者使用。

For more information, please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca..

欲了解更多信息，请访问www.astrazeneca-us.com，并在社交媒体@astrazeneca上关注我们。。

US-89716 Last Updated 5/24

US-89716上次更新时间：5月24日