PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced results from the Phase 3 CheckMate -8HW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) as a first-line treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

普林斯顿，新泽西州（商业新闻短讯）--百时美施贵宝（纽约证券交易所：BMY）今天宣布了第三阶段CheckMate-8HW试验的结果，该试验评估了Opdivo（nivolumab）加Yervoy（ipilimumab）与研究者选择的化疗（mFOLFOX-6或FOLFIRI加或不加贝伐单抗或西妥昔单抗）作为微卫星不稳定性高（MSI-H）或错配修复患者的一线治疗缺陷型（dMMR）转移性结直肠癌（mCRC）。

The dual immunotherapy combination of Opdivo and Yervoy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR), with a reduction in the risk of disease progression or death by 79% (Hazard Ratio [HR]: 0.21; 95% Confidence Interval [CI]: 0.14-0.32; p<0.0001) compared to chemotherapy in patients with centrally confirmed MSI-H/dMMR mCRC..

Opdivo和Yervoy的双重免疫治疗组合显示，通过盲法独立中央审查（BICR）评估，无进展生存期（PFS）的主要终点有统计学意义和临床意义的改善，与中心确诊的MSI-H/dMMR mCRC患者的化疗相比，疾病进展或死亡风险降低了79%（风险比[HR]:0.21；95%置信区间[CI]:0.14-0.32；p<0.0001）。。

These late-breaking data (Abstract #LBA768) will be featured in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium on Saturday, January 20 at 9:15 a.m. Pacific Time and will be highlighted as part of the Congress’ official press program.

这些最新数据（摘要#LBA768）将于太平洋时间1月20日星期六上午9:15在2024年美国临床肿瘤学会（ASCO）胃肠道癌症研讨会上进行口头介绍，并将作为国会官方新闻节目的一部分予以强调。

Improvement in PFS was noted beginning at approximately three months and was sustained throughout. Median PFS was not yet reached in the Opdivo plus Yervoy arm (95% CI: 38.4-NE) vs. 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8). Consistent PFS benefit was observed across all pre-specified subgroups, including patients with KRAS or NRAS mutations, and those with baseline liver, lung, or peritoneal metastases..

从大约三个月开始注意到PFS的改善，并且一直持续。Opdivo加Yervoy组的中位PFS尚未达到（95%可信区间：38.4-NE），而化疗组为5.9个月（95%可信区间：4.4-7.8）。在所有预先指定的亚组中，包括KRAS或NRAS突变患者，以及基线肝，肺或腹膜转移患者，均观察到一致的PFS获益。。

The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. Grade 3/4 treatment-related adverse events (TRAEs) occurred in 23% of patients in the Opdivo plus Yervoy arm and 48% of patients in the chemotherapy arm.

Opdivo加Yervoy组合的安全性概况与先前报告的数据保持一致，并且可以通过既定协议进行管理，没有发现新的安全信号。Opdivo加Yervoy组23%的患者和化疗组48%的患者发生3/4级治疗相关不良事件（TRAEs）。

Any grade TRAE-related discontinuation was 17% in the Opdivo plus Yervoy arm and 32% in the chemotherapy arm..

Opdivo加Yervoy组的任何TRAE相关停药率为17%，化疗组为32%。。

“Patients with MSI-H/dMMR metastatic colorectal cancer are less likely to benefit from chemotherapy,” said Thierry Andre, M.D., Head of the Medical Oncology Department, Sorbonne University and Hospital Saint-Antoine, Paris, France. “An impressive improvement in PFS and sustained benefit beginning at three months was observed with nivolumab plus ipilimumab versus chemotherapy in this trial.

“MSI-H/dMMR转移性结直肠癌患者不太可能从化疗中受益，”法国巴黎索邦大学和圣安托万医院肿瘤内科主任Thierry Andre医学博士说。“在这项试验中，nivolumab加ipilimumab与化疗相比，从三个月开始观察到PFS的显着改善和持续获益。

These results demonstrate the meaningful efficacy of this combination with practice-changing potential for this patient population.”.

这些结果证明了这种组合的有意义的功效，以及这种患者群体改变实践的潜力。”。

Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first line treatment in MSI-H/dMMR mCRC.

Opdivo plus Yervoy是第一个双重免疫治疗方案，与化疗相比，作为MSI-H/dMMR mCRC的一线治疗显示出显着的疗效益处。

“With research from the full CheckMate clinical development program, BMS has revolutionized the oncology landscape and helped change survival expectations for people with cancer. Today, with these data from CheckMate -8HW, we showed that Opdivo plus Yervoy reduced the risk of disease progression or death by an unprecedented 79%,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb.

医学博士、医学科学院副院长达纳·沃克（Dana Walker）说：“通过全面的CheckMate临床开发计划的研究，BMS彻底改变了肿瘤学领域，并帮助改变了癌症患者的生存期望。今天，通过CheckMate-8HW的这些数据，我们发现Opdivo加Yervoy可以将疾病进展或死亡的风险降低79%，这是前所未有的。”，全球计划负责人，胃肠道和泌尿生殖系统癌症，百时美施贵宝。

“These results build on the benefit of Opdivo and Yervoy in MSI-H/dMMR metastatic colorectal cancer as previously demonstrated in CheckMate -142 and reinforce our commitment to exploring the potential of these therapies to help more patients in need.'.

“这些结果建立在Opdivo和Yervoy在MSI-H/dMMR转移性结直肠癌中的益处的基础上，如先前在CheckMate-142中所证明的，并加强了我们探索这些疗法的潜力以帮助更多需要帮助的患者的承诺。”。

CheckMate -8HW is ongoing to assess the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints, including overall survival (OS).

CheckMate-8HW正在评估接受Opdivo加Yervoy治疗的患者PFS的第二个双重主要终点，与所有治疗方案中单独使用Opdivo相比，以及次要终点，包括总生存期（OS）。

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

百时美施贵宝感谢参与CheckMate-8HW临床试验的患者和研究人员。

About CheckMate -8HW

关于CheckMate-8HW

CheckMate -8HW (NCT04008030) is a Phase 3 randomized, open-label trial evaluating Opdivo plus Yervoy compared to Opdivo alone or investigator’s choice chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC)..

CheckMate-8HW（NCT04008030）是一项3期随机开放标签试验，评估Opdivo加Yervoy与单独使用Opdivo或研究者选择的化疗（mFOLFOX-6或FOLFIRI联合或不联合贝伐单抗或西妥昔单抗）治疗微卫星不稳定性高（MSI-H）或错配修复缺陷（dMMR）转移性结直肠癌（mCRC）患者的疗效。。

Approximately 830 patients were randomized to receive either Opdivo monotherapy (Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W), or investigator’s choice of chemotherapy. The dual primary endpoints of the trial are progression-free survival (PFS) per blinded independent central review (BICR) for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in the first line setting and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy.

大约830名患者被随机分配接受Opdivo单药治疗（Opdivo 240 mg Q2W六剂，其次是Opdivo 480 mg Q4W），Opdivo加Yervoy（Opdivo 240 mg加Yervoy 1 mg/kg Q3W四剂，然后是Opdivo 480 mg Q4W）或研究者选择的化疗。该试验的双重主要终点是Opdivo加Yervoy的每个盲法独立中心评价（BICR）的无进展生存期（PFS），与研究者在一线治疗中选择的化疗相比，以及Opdivo加Yervoy的每个BICR的PFS与Opdivo单独治疗相比。

The trial also includes several secondary safety and efficacy endpoints, including overall survival (OS)..

该试验还包括几个次要安全性和有效性终点，包括总生存期（OS）。。

The study is ongoing to assess the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints.

该研究正在进行中，以评估接受Opdivo加Yervoy治疗的患者PFS的第二个双重主要终点，与所有治疗方案中单独使用Opdivo相比，以及次要终点。

About MSI-H or dMMR Colorectal Cancer

关于MSI-H或dMMR结直肠癌

Colorectal cancer (CRC) is a cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined..

结直肠癌（CRC）是一种发生在结肠或直肠的癌症，结肠或直肠是人体消化或胃肠系统的一部分。CRC是世界上第三大最常诊断的癌症。2020年，估计约有1931000例新病例；它是男性和女性癌症相关死亡的第二大原因。。

Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. Approximately 5-7% of metastatic CRC patients have dMMR or MSI-H tumors; they are less likely to benefit from conventional chemotherapy and typically have a poor prognosis..

错配修复缺陷（dMMR）发生在修复DNA复制中错配错误的蛋白质缺失或无功能时，导致微卫星不稳定性高（MSI-H）肿瘤。大约5-7%的转移性CRC患者患有dMMR或MSI-H肿瘤；他们不太可能从常规化疗中受益，通常预后较差。。

Bristol Myers Squibb: Creating a Better Future for People with Cancer

百时美施贵宝：为癌症患者创造更美好的未来

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus.

百时美施贵宝的灵感来自一个单一的愿景——通过科学改变患者的生活。该公司癌症研究的目标是提供药物，为每位患者提供更好、更健康的生活，并使治愈成为可能。百时美施贵宝（Bristol-Myers Squibb）的研究人员正在探索个性化医学的新前沿，并通过创新的数字平台，将数据转化为见解，从而提高他们的关注度。

Deep understanding of causal human biology, cutting-edge capabilities and differentiated research programs uniquely position the company to approach cancer from every angle..

对因果人类生物学的深刻理解、尖端能力和差异化研究计划使公司能够从各个角度处理癌症。。

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future..

癌症可以无情地影响患者生活的许多方面，百时美施贵宝致力于采取行动解决护理的各个方面，从诊断到生存。作为癌症治疗领域的领导者，百时美施贵宝正在努力让所有癌症患者拥有更好的未来。。

About Opdivo

关于Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers..

Opdivo是一种程序性死亡-1（PD-1）免疫检查点抑制剂，旨在独特地利用人体自身的免疫系统来帮助恢复抗肿瘤免疫反应。通过利用人体自身的免疫系统对抗癌症，Opdivo已成为多种癌症的重要治疗选择。。

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Opdivo领先的全球发展计划基于百时美施贵宝在免疫肿瘤学领域的科学专业知识，包括各种肿瘤类型的所有阶段（包括第3阶段）的广泛临床试验。迄今为止，Opdivo临床开发计划已经治疗了35000多名患者。

The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression..

Opdivo试验有助于更深入地了解生物标志物在患者护理中的潜在作用，特别是关于患者如何在PD-L1表达的连续过程中从Opdivo中受益。。

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union..

2014年7月，Opdivo是世界上第一个获得监管批准的PD-1免疫检查点抑制剂。Opdivo目前已在65多个国家获得批准，包括美国、欧盟、日本和中国。2015年9月，该公司的Opdivo和Yervoy联合方案是第一个获得监管部门批准用于治疗转移性黑色素瘤的免疫肿瘤学联合方案，目前已在包括美国和欧盟在内的50多个国家获得批准。。

About Yervoy

关于Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells.

Yervoy是一种重组人单克隆抗体，可与细胞毒性T淋巴细胞相关抗原-4（CTLA-4）结合。CTLA-4是T细胞活性的负调节剂。Yervoy与CTLA-4结合并阻断CTLA-4与其配体CD80/CD86的相互作用。已显示阻断CTLA-4可增强T细胞活化和增殖，包括肿瘤浸润性T效应细胞的活化和增殖。

Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma.

抑制CTLA-4信号传导也可以降低T调节细胞功能，这可能有助于T细胞反应性的普遍增加，包括抗肿瘤免疫应答。2011年3月25日，美国食品和药物管理局（FDA）批准Yervoy 3 mg/kg单药治疗不可切除或转移性黑色素瘤患者。

Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types..

Yervoy在50多个国家被批准用于不可切除或转移性黑色素瘤。Yervoy有一个广泛的，持续的发展计划，跨越多种肿瘤类型。。

INDICATIONS

适应症

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO®（nivolumab）作为单一药物，适用于治疗12岁及以上不可切除或转移性黑色素瘤的成人和儿科患者。

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO®（nivolumab）与YERVOY®（ipilimumab）联合用于治疗12岁及以上不可切除或转移性黑色素瘤的成人和儿科患者。

OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

OPDIVO®适用于12岁及以上完全切除IIB期，IIC期，III期或IV期黑色素瘤的成人和儿科患者的辅助治疗。

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO®（nivolumab）联合铂类双联化疗被认为是可切除（肿瘤≥4 cm或淋巴结阳性）非小细胞肺癌（NSCLC）成年患者的新辅助治疗。

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO®（nivolumab）与YERVOY®（ipilimumab）联合用于转移性非小细胞肺癌（NSCLC）成年患者的一线治疗，其肿瘤表达PD-L1（≥1%），通过FDA批准的测试确定，没有EGFR或ALK基因组肿瘤畸变。

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO®（nivolumab）联合YERVOY®（ipilimumab）和2个周期的铂类双联化疗，适用于转移性或复发性非小细胞肺癌（NSCLC）成人患者的一线治疗，无EGFR或ALK基因组肿瘤畸变。

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO..

OPDIVO®（nivolumab）适用于治疗成人转移性非小细胞肺癌（NSCLC）患者，铂类化疗时或化疗后进展。患有EGFR或ALK基因组肿瘤畸变的患者在接受OPDIVO之前，应在FDA批准的这些畸变治疗中取得疾病进展。。

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO®（nivolumab）与YERVOY®（ipilimumab）联合用于成人不可切除恶性胸膜间皮瘤（MPM）患者的一线治疗。

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO®（nivolumab）与YERVOY®（ipilimumab）联合用于中危或低危晚期肾细胞癌（RCC）成年患者的一线治疗。

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO®（nivolumab）与cabozantinib联合用于成人晚期肾细胞癌（RCC）患者的一线治疗。

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO®（nivolumab）适用于治疗先前接受过抗血管生成治疗的成年晚期肾细胞癌（RCC）患者。

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT.

OPDIVO®（nivolumab）适用于治疗成人经典霍奇金淋巴瘤（cHL）患者，这些患者在自体造血干细胞移植（HSCT）和brentuximab vedotin或包括自体HSCT在内的3种或更多种全身治疗后复发或进展。

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

根据总体回复率，该适应症在加速批准下获得批准。是否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。。

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO®（nivolumab）适用于治疗成人头颈部复发或转移性鳞状细胞癌（SCCHN）患者，铂类药物治疗时或治疗后疾病进展。

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy..

OPDIVO®（nivolumab）适用于治疗局部晚期或转移性尿路上皮癌的成年患者，这些患者在含铂化疗期间或之后有疾病进展，或者在新辅助治疗或含铂化疗辅助治疗后12个月内有疾病进展。。

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO®（nivolumab）作为单一药物，适用于成年尿路上皮癌（UC）患者的辅助治疗，这些患者在接受UC根治性切除术后复发风险很高。

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

OPDIVO®（nivolumab）作为单一药物，适用于治疗成人和儿科（12岁及以上）微卫星不稳定性高（MSI-H）或错配修复缺陷（dMMR）转移性结直肠癌（CRC）的患者，这些患者在用氟嘧啶，奥沙利铂和伊立替康治疗后取得了进展。

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

根据总体响应率和响应持续时间，该适应症在加速批准下获得批准。是否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。。

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

OPDIVO®（nivolumab）与YERVOY®（ipilimumab）联合用于治疗12岁及以上微卫星不稳定性高（MSI-H）或错配修复缺陷（dMMR）转移性结直肠癌（CRC）的成人和儿科患者，这些患者在用氟嘧啶，奥沙利铂和伊立替康治疗后进展。

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

根据总体响应率和响应持续时间，该适应症在加速批准下获得批准。是否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。。

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response.

OPDIVO®（nivolumab）与YERVOY®（ipilimumab）联合用于治疗先前接受索拉非尼治疗的成年肝细胞癌（HCC）患者。根据总体响应率和响应持续时间，该适应症在加速批准下获得批准。

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials..

是否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。。

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO®（nivolumab）适用于治疗先前氟嘧啶和铂类化疗后无法切除的晚期，复发或转移性食管鳞状细胞癌（ESCC）的成年患者。

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO®（nivolumab）适用于接受新辅助放化疗（CRT）的成年患者中完全切除的食管癌或胃食管交界癌伴残留病理疾病的辅助治疗。

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO®（nivolumab）联合含氟嘧啶和铂的化疗，适用于不可切除的晚期或转移性食管鳞状细胞癌（ESCC）成年患者的一线治疗。

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO®（nivolumab）与YERVOY®（ipilimumab）联合用于不可切除的晚期或转移性食管鳞状细胞癌（ESCC）成年患者的一线治疗。

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

OPDIVO®（nivolumab）与含氟嘧啶和铂的化疗联合用于治疗晚期或转移性胃癌，胃食管连接癌和食管腺癌的成年患者。

IMPORTANT SAFETY INFORMATION

重要安全信息

Severe and Fatal Immune-Mediated Adverse Reactions

严重致命的免疫介导的不良反应

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.

本文列出的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的不良反应。

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY.

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。虽然免疫介导的不良反应通常在治疗期间表现出来，但它们也可能在停用OPDIVO或YERVOY后发生。早期识别和管理对于确保OPDIVO和YERVOY的安全使用至关重要。

Monitor for signs and symptoms 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 periodically during treatment with OPDIVO and before each dose of YERVOY.

监测可能是潜在免疫介导的不良反应的临床表现的体征和症状。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，在基线和OPDIVO治疗期间以及每次服用YERVOY之前定期进行评估。

In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate..

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。及时进行医疗管理，包括适当的专业咨询。。

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less.

根据严重程度扣留或永久停用OPDIVO和YERVOY（请参阅随附的完整处方信息中的第2节剂量和给药）。一般来说，如果需要OPDIVO或YERVOY中断或停药，则给予全身皮质类固醇治疗（1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. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below..

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。考虑在免疫介导的不良反应不能用皮质类固醇治疗控制的患者中使用其他全身免疫抑制剂。下面讨论不一定需要全身类固醇（例如内分泌病和皮肤病反应）的不良反应的毒性管理指南。。

Immune-Mediated Pneumonitis

免疫介导性肺炎

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%).

OPDIVO和YERVOY可引起免疫介导的肺炎。先前接受过胸部放疗的患者肺炎的发生率较高。在接受OPDIVO单药治疗的患者中，免疫介导的肺炎发生率为3.1%（61/1994），包括4级（<0.1%），3级（0.9%）和2级（2.1%）。

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%).

在每3周接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg的患者中，7%（31/456）的患者发生免疫介导的肺炎，包括4级（0.2%），3级（2.0%）和2级（4.4%）。在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的患者中，免疫介导的肺炎发生率为3.9%（26/666），包括3级（1.4%）和2级（2.6%）。

In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune- mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis..

在每2周服用OPDIVO 3 mg/kg，每6周服用YERVOY 1 mg/kg的NSCLC患者中，9%（50/576）的患者发生免疫介导的肺炎，包括4级（0.5%），3级（3.5%）和2级（4.0%）。4名患者（0.7%）死于肺炎。。

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

在Checkmate 205和039中，接受OPDIVO治疗的患者中有6.0%（16/266）发生肺炎，包括间质性肺病。接受OPDIVO治疗的患者中有4.9%（13/266）发生免疫介导的肺炎，包括3级（n=1）和2级（n=12）。

Immune-Mediated Colitis

免疫介导的结肠炎

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was 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.

OPDIVO和YERVOY可引起免疫介导的结肠炎，这可能是致命的。结肠炎定义中的常见症状是腹泻。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。

In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%)..

在接受OPDIVO单药治疗的患者中，2.9%（58/1994）的患者发生了免疫介导的结肠炎，包括3级（1.7%）和2级（1%）。。

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%)..

在每3周接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg的患者中，25%（115/456）的患者发生免疫介导的结肠炎，包括4级（0.4%），3级（14%）和2级（8%）。在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的患者中，9%（60/666）的患者发生免疫介导的结肠炎，包括3级（4.4%）和2级（3.7%）。。

Immune-Mediated Hepatitis and Hepatotoxicity

免疫介导的肝炎和肝毒性

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

OPDIVO和YERVOY可引起免疫介导的肝炎。在接受OPDIVO单药治疗的患者中，1.8%（35/1994）的患者发生免疫介导的肝炎，包括4级（0.2%），3级（1.3%）和2级（0.4%）。

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%)..

在每3周接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg的患者中，15%（70/456）的患者发生免疫介导的肝炎，包括4级（2.4%），3级（11%）和2级（1.8%）。在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的患者中，7%（48/666）的患者发生免疫介导的肝炎，包括4级（1.2%），3级（4.9%）和2级（0.4%）。。

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients..

与单独使用OPDIVO相比，OPDIVO联合cabozantinib可引起肝毒性，3级和4级ALT和AST升高的频率更高。与作为单一药物给药时相比，考虑更频繁地监测肝酶。在接受OPDIVO和cabozantinib治疗的患者中，11%的患者出现3级和4级ALT或AST升高。。

Immune-Mediated Endocrinopathies

免疫介导的内分泌病

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

OPDIVO和YERVOY可引起原发性或继发性肾上腺皮质功能不全，免疫介导的垂体炎，免疫介导的甲状腺疾病和1型糖尿病，并可伴有糖尿病酮症酸中毒。根据严重程度扣留OPDIVO和YERVOY（请参阅随附的完整处方信息中的第2节剂量和给药）。

For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated.

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。垂体炎可出现与肿块效应相关的急性症状，例如头痛，畏光或视野缺陷。垂体炎可引起垂体功能减退；根据临床指示开始激素替代。

Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated..

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甲状腺功能亢进症；根据临床指示开始激素替代或医疗管理。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。。

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%).

在接受OPDIVO单药治疗的患者中，肾上腺功能不全发生率为1%（20/1994），包括3级（0.4%）和2级（0.6%）。在每3周接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg的患者中，肾上腺功能不全发生率为8%（35/456），包括4级（0.2%），3级（2.4%）和2级（4.2%）。

In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%)..

在接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg每3周一次的患者中，肾上腺功能不全发生率为7%（48/666），包括4级（0.3%），3级（2.5%）和2级（4.1%）。在接受OPDIVO和cabozantinib的患者中，肾上腺功能不全发生率为4.7%（15/320），包括3级（2.2%）和2级（1.9%）。。

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%).

在接受OPDIVO单药治疗的患者中，0.6%（12/1994）的患者发生垂体炎，包括3级（0.2%）和2级（0.3%）。

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%)..

在每3周接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg的患者中，垂体炎发生率为9%（42/456），包括3级（2.4%）和2级（6%）。在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的患者中，4.4%（29/666）的患者发生垂体炎，包括4级（0.3%），3级（2.4%）和2级（0.9%）。。

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.5%) and Grade 2 (2.2%).

在接受OPDIVO单药治疗的患者中，甲状腺炎发生率为0.6%（12/1994），包括2级（0.2%）。在接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg每3周治疗的患者中，甲状腺炎发生率为2.7%（22/666），包括3级（4.5%）和2级（2.2%）。

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%).

在接受OPDIVO单药治疗的患者中，甲状腺功能亢进发生率为2.7%（54/1994），包括3级（<0.1%）和2级（1.2%）。在接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg每3周治疗的患者中，甲状腺功能亢进发生率为9%（42/456），包括3级（0.9%）和2级（4.2%）。

In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%)..

在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的患者中，12%（80/666）的患者发生甲状腺功能亢进，包括3级（0.6%）和2级（4.5%）。。

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%).

在接受OPDIVO单药治疗的患者中，甲状腺功能减退发生率为8%（163/1994），包括3级（0.2%）和2级（4.8%）。在每3周接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg的患者中，甲状腺功能减退发生率为20%（91/456），包括3级（0.4%）和2级（11%）。

In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%)..

在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的患者中，18%（122/666）的患者发生甲状腺功能减退，包括3级（0.6%）和2级（11%）。。

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%)..

在接受OPDIVO单药治疗的患者中，糖尿病发生率为0.9%（17/1994），包括3级（0.4%）和2级（0.3%），以及2例糖尿病酮症酸中毒。在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的患者中，2.7%（15/666）的患者发生糖尿病，包括4级（0.6%），3级（0.3%）和2级（0.9%）。。

Immune-Mediated Nephritis with Renal Dysfunction

免疫介导性肾炎伴肾功能不全

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%)..

OPDIVO和YERVOY可引起免疫介导的肾炎。在接受OPDIVO单药治疗的患者中，1.2%（23/1994）的患者发生免疫介导性肾炎和肾功能不全，包括4级（<0.1%），3级（0.5%）和2级（0.6%）。在接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg每3周治疗的患者中，4.1%（27/666）的患者发生免疫介导性肾炎并肾功能不全，包括4级（0.6%），3级（1.1%），和2级（2.2%）。。

Immune-Mediated Dermatologic Adverse Reactions

免疫介导的皮肤病不良反应

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes..

OPDIVO可引起免疫介导的皮疹或皮炎。PD-1/PD-L1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），中毒性表皮坏死松解症（TEN）和伴有嗜酸性粒细胞增多和全身症状的药疹（DRESS）。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风湿性皮疹。。

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.

YERVOY可引起免疫介导的皮疹或皮炎，包括大疱性和剥脱性皮炎，SJS，TEN和DRESS。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大疱性/剥脱性皮疹。

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

根据严重程度扣留或永久停用OPDIVO和YERVOY（请参阅随附的完整处方信息中的第2节剂量和给药）。

In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated rash occurred in 28% (127/456) of patients, including Grade 3 (4.8%) and Grade 2 (10%).

在接受OPDIVO单药治疗的患者中，9%（171/1994）的患者发生免疫介导的皮疹，包括3级（1.1%）和2级（2.2%）。在接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg每3周的患者中，28%（127/456）的患者发生免疫介导的皮疹，包括3级（4.8%）和2级（10%）。

In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated rash occurred in 16% (108/666) of patients, including Grade 3 (3.5%) and Grade 2 (4.2%)..

在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的患者中，16%（108/666）的患者发生免疫介导的皮疹，包括3级（3.5%）和2级（4.2%）。。

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 <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection..

在接受OPDIVO单药治疗或OPDIVO联合YERVOY治疗或报告使用其他PD-1/PD-L1阻断抗体的患者中，以下临床显着的免疫介导的不良反应发生率<1%（除非另有说明）。据报道，其中一些不良反应有严重或致命的病例：心脏/血管：心肌炎，心包炎，血管炎；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；眼部：可能发生葡萄膜炎，虹膜炎和其他眼部炎症毒性；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；肌肉骨骼和结缔组织：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；内分泌：甲状旁腺功能减退；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（HLH），全身炎症反应综合征，组织细胞坏死性淋巴结炎（Kikuchi淋巴结炎），结节病，免疫性血小板减少性紫癜，实体器官移植排斥反应。。

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis..

除了上面列出的免疫介导的不良反应外，在YERVOY单一疗法或与OPDIVO联合的临床试验中，除非另有说明，否则<1%的患者发生以下临床上显着的免疫介导的不良反应，其中一些具有致命的结果：神经系统：自身免疫性神经病（2%），肌无力综合征/重症肌无力，运动功能障碍；心血管：血管病，颞动脉炎；眼部：睑缘炎，巩膜炎，眼眶肌炎，巩膜炎；胃肠道：胰腺炎（1.3%）；其他（血液学/免疫）：结膜炎，血细胞减少症（2.5%），嗜酸性粒细胞增多症（2.1%），多形性红斑，超敏性血管炎，神经感觉性视力减退，牛皮癣。。

Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss..

一些眼部IMAR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，请考虑在接受OPDIVO和YERVOY治疗的患者中观察到的Vogt-Koyanagi-Harada样综合征，因为这可能需要使用全身皮质类固醇治疗以降低永久性视力丧失的风险。。

Infusion-Related Reactions

输液相关反应

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions.

OPDIVO和YERVOY可引起严重的输液相关反应。对于严重（3级）或危及生命（4级）输注相关反应的患者，停止使用OPDIVO和YERVOY。轻度（1级）或中度（2级）输液相关反应患者中断或减慢输液速度。

In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30- minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively.

在接受OPDIVO单药治疗60分钟输注的患者中，6.4%（127/1994）的患者发生了输注相关反应。在一项单独的试验中，患者接受OPDIVO单药治疗60分钟输注或30分钟输注，分别有2.2%（8/368）和2.7%（10/369）的患者发生输注相关反应。

Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients.

此外，分别有0.5%（2/368）和1.4%（5/369）的患者在输注后48小时内出现不良反应，导致剂量延迟，永久停药或停用OPDIVO。在每3周接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg的黑色素瘤患者中，2.5%（10/407）的患者发生了输注相关反应。

In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI- H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 4.2% (5/119) of patients.

在每3周接受OPDIVO 1 mg/kg和YERVOY 3 mg/kg的HCC患者中，8%（4/49）的患者发生输注相关反应。在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的RCC患者中，5.1%（28/547）的患者发生了输注相关反应。在每3周接受OPDIVO 3 mg/kg和YERVOY 1 mg/kg的MSI-H/dMMR mCRC患者中，4.2%（5/119）的患者发生输注相关反应。

In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients..

在MPM患者中，每2周接受OPDIVO 3 mg/kg，每6周接受YERVOY 1 mg/kg，12%（37/300）的患者发生输注相关反应。。

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

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 OPDIVO or YERVOY. 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OPDIVO或YERVOY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 OPDIVO or YERVOY and allogeneic HSCT..

尽管OPDIVO或YERVOY与同种异体HSCT之间进行了干预治疗，但仍可能发生这些并发症。。

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.

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OPDIVO和YERVOY治疗的益处与风险。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus.

根据其作用机制和动物研究的结果，OPDIVO和YERVOY给孕妇服用时会造成胎儿伤害。YERVOY在妊娠中期和晚期的影响可能更大。告知孕妇对胎儿的潜在风险。

Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose..

建议有生殖潜力的女性在使用OPDIVO和YERVOY治疗期间以及最后一次服用后至少5个月内使用有效的避孕措施。。

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

当将OPDIVO添加到沙利度胺类似物和地塞米松中时，多发性骨髓瘤患者的死亡率增加

In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials..

在多发性骨髓瘤患者的随机临床试验中，在沙利度胺类似物加地塞米松中加入OPDIVO导致死亡率增加。在对照临床试验之外，不建议使用PD-1或PD-L1阻断抗体联合沙利度胺类似物加地塞米松治疗多发性骨髓瘤患者。。

Lactation

哺乳期

There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose..

没有关于母乳中存在OPDIVO或YERVOY，对母乳喂养的孩子的影响或对牛奶生产的影响的数据。由于母乳喂养的儿童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服用后的5个月内不要母乳喂养。。

Serious Adverse Reactions

严重不良反应

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase.

在Checkmate 037中，41%接受OPDIVO治疗的患者发生严重不良反应（n=268）。42%接受OPDIVO治疗的患者发生3级和4级不良反应。在接受OPDIVO治疗的患者中，2%至5%的患者报告的最常见的3级和4级不良反应是腹痛，低钠血症，天冬氨酸转氨酶升高和脂肪酶升高。

In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%).

在Checkmate 066中，36%接受OPDIVO治疗的患者发生严重不良反应（n=206）。41%接受OPDIVO治疗的患者发生3级和4级不良反应。在接受OPDIVO治疗的患者中，≥2%的患者报告的最常见的3级和4级不良反应是γ-谷氨酰转移酶升高（3.9%）和腹泻（3.4%）。

In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313).

在Checkmate 067中，严重不良反应（74%和44%），导致永久停药（47%和18%）或给药延迟（58%和36%）的不良反应，以及3级或4级不良反应（72%和51%）在OPDIVO加YERVOY组（n=313）中相对于OPDIVO组（n=313）更频繁地发生。

The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 238, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=452). Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452).

OPDIVO加YERVOY组和OPDIVO组最常见（≥10%）的严重不良反应分别为腹泻（13%和2.2%），结肠炎（10%和1.9%）和发热（10%和1.0%）。在Checkmate 238中，接受OPDIVO的患者中有18%发生严重不良反应（n=452）。25%的OPDIVO治疗患者（n=452）发生3级或4级不良反应。

The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. In Checkmate 816, serious adverse reactions occurred in 30% of patients (n=176) who were treated with OPDIVO in combination with platinum-doublet chemotherapy.

在≥2%的OPDIVO治疗患者中报告的最常见的3级和4级不良反应是腹泻以及脂肪酶和淀粉酶升高。在Checkmate 816中，接受OPDIVO联合铂类双联化疗的患者中有30%（n=176）发生严重不良反应。

Serious adverse reactions in >2% included pneumonia and vomiting. No fatal adverse reactio.

>2%的严重不良反应包括肺炎和呕吐。无致命不良反应。

Common Adverse Reactions

常见不良反应

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%).

在Checkmate 037中，OPDIVO（n=268）报告的最常见不良反应（≥20%）是皮疹（21%）。在Checkmate 066中，OPDIVO（n=206）与达卡巴嗪（n=205）报告的最常见不良反应（≥20%）是疲劳（49%比39%），肌肉骨骼疼痛（32%比25%），皮疹（28%比12%）和瘙痒（23%比12%）。

In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%).

在Checkmate 067中，OPDIVO加YERVOY组（n=313）最常见（≥20%）的不良反应是疲劳（62%），腹泻（54%），皮疹（53%），恶心（44%），发热（40%），瘙痒（39%），肌肉骨骼疼痛（32%），呕吐（31%），食欲下降（29%），咳嗽（27%），头痛（26%），呼吸困难（24%），上呼吸道感染（23%），关节痛（21%）和转氨酶升高（25%）。

In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%).

在Checkmate 067中，OPDIVO组（n=313）最常见（≥20%）的不良反应是疲劳（59%），皮疹（40%），肌肉骨骼疼痛（42%），腹泻（36%），恶心（30%），咳嗽（28%），瘙痒（27%），上呼吸道感染（22%），食欲下降（22%），头痛（22%），便秘（21%），关节痛（21%）和呕吐（20%）。

In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%).

在Checkmate 238中，OPDIVO治疗患者（n=452）与ipilimumab治疗患者（n=453）报告的最常见不良反应（≥20%）是疲劳（57%比55%），腹泻（37%比55%），皮疹（35%比47%），肌肉骨骼疼痛（32%比27%），瘙痒（28%比37%），头痛（23%比31%），恶心（23%比28%），上呼吸道感染（22%比15%）和腹痛（21%比23%）。

The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Checkmate 816, the most common (>20%) adverse reactions in the OPDIVO plus chemotherapy arm (n=176) were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%).

最常见的免疫介导的不良反应是皮疹（16%），腹泻/结肠炎（6%）和肝炎（3%）。在Checkmate 816中，OPDIVO加化疗组（n=176）最常见（>20%）的不良反应是恶心（38%），便秘（34%），疲劳（26%），食欲下降（20%）和皮疹（20%）。

In Checkmate 227, the most common (≥20.

在Checkmate 227中，最常见的（≥20。

Please see US Full Prescribing Information for OPDIVO and YERVOY.

请参阅OPDIVO和YERVOY的完整处方信息。

Clinical Trials and Patient Populations

临床试验和患者人群

Checkmate 227—previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 649–previously untreated advanced or metastatic gastric cancer, gastroesophageal junction and esophageal adenocarcinoma; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 238– adjuvant treatment of patients with completely resected Stage III or Stage IV melanoma; Checkmate 76K– adjuvant treatment of patients 12 years of age and older with completely resected Stage IIB or Stage IIC melanoma; Checkmate 274–adjuvant treatment of urothelial carcinoma; Checkmate 275–previously treated advanced or metastatic urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Attraction-3–esophageal squamous cell carcinoma; Checkmate 648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma; Checkmate 648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma; Checkmate 040–hepatocellular carcinoma, in combination with YERVOY; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 037–previously treated metastatic melanoma; Checkmate 066—previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic s.

Checkmate 227先前未经治疗的转移性非小细胞肺癌，与YERVOY联合使用；Checkmate 9LA–以前未经治疗的复发或转移性非小细胞肺癌，结合YERVOY和2个周期的铂双联化疗（通过组织学）；Checkmate 649–以前未经治疗的晚期或转移性胃癌，胃食管交界处和食管腺癌；Checkmate 577–食管癌或胃食管交界癌的辅助治疗；Checkmate 238–完全切除的III期或IV期黑色素瘤患者的辅助治疗；Checkmate 76K–12岁及以上完全切除的IIB期或IIC期黑色素瘤患者的辅助治疗；Checkmate 274–尿路上皮癌的辅助治疗；Checkmate 275–先前治疗的晚期或转移性尿路上皮癌；Checkmate 142–MSI-H或dMMR转移性结直肠癌，作为单一药物或与YERVOY联合使用；Checkmate 142–MSI-H或dMMR转移性结直肠癌，作为单一药物或与YERVOY联合使用；Attraction-3–食管鳞状细胞癌；Checkmate 648以前未经治疗，不可切除的晚期复发或转移性食管鳞状细胞癌；Checkmate 648以前未经治疗，不可切除的晚期复发或转移性食管鳞状细胞癌；Checkmate 040–肝细胞癌，与YERVOY联合使用；Checkmate 743-以前未经治疗的不可切除的恶性胸膜间皮瘤，与YERVOY联合使用；Checkmate 037–先前治疗的转移性黑色素瘤；Checkmate 066以前未经治疗的转移性黑色素瘤；Checkmate 067–以前未经治疗的转移性黑色素瘤，作为单一药物或与YERVOY联合使用；Checkmate 017–转移性s的二线治疗。

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

关于百时美施贵宝和小野制药的合作

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan..

2011年，百时美施贵宝通过与小野制药公司的合作协议，扩大了其在全球范围内开发和商业化Opdivo的领土权利，但日本、韩国和台湾除外，小野当时保留了该化合物的所有权利。2014年7月23日，小野和百时美施贵宝进一步扩大了公司的战略合作协议，共同开发和商业化多种免疫疗法，作为单一药物和联合方案，用于日本、韩国和台湾的癌症患者。。

About Bristol Myers Squibb

关于百时美施贵宝

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram..

百时美施贵宝是一家全球生物制药公司，其使命是发现、开发和提供创新药物，帮助患者战胜严重疾病。有关百时美施贵宝的更多信息，请访问BMS.com或在LinkedIn、Twitter、YouTube、Facebook和Instagram上关注我们。。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示声明

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的“前瞻性声明”，其中涉及药品的研究、开发和商业化。所有不属于历史事实陈述的陈述都是或可能被视为前瞻性陈述。

Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements.

此类前瞻性陈述基于对我们未来财务业绩、目标、计划和目标的当前预期和预测，涉及固有风险、假设和不确定性，包括可能在未来几年延迟、转移或改变其中任何一个的难以预测的内部或外部因素，可能超出我们的控制范围，并可能导致我们未来的财务结果、目标、计划和目标与报表中表达或暗示的财务结果、目标、计划和目标存在重大差异。

These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that Opdivo in combination with Yervoy  may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such combination treatment for such additional indication described in this release will be commercially successful.

这些风险、假设、不确定性和其他因素包括，未来的研究结果可能与迄今为止的结果不一致，Opdivo与Yervoy的组合可能不会在当前预期的时间表内获得监管部门对本版本中描述的其他指征的批准，或者根本不会获得任何营销批准，可能对其使用有重大限制，并且如果获得批准，对于本版本中描述的此类额外适应症的这种联合治疗是否会取得商业成功。

No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Fo.

不能保证前瞻性声明。本新闻稿中的前瞻性陈述应与影响百时美施贵宝业务和市场的许多风险和不确定性一起进行评估，特别是在百时美施贵宝Fo年度报告中的警示声明和风险因素讨论中确定的风险和不确定性。

corporatefinancial-news

企业财经新闻