Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease

侵袭性疾病患者联合治疗的中位反应持续时间达到7.4个月

New results show potential of RYBREVANT® beyond lung cancer

新结果显示RYBREVANT®超越肺癌的潜力

BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new data from the Phase 1b/2 OrigAMI-1 study, which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy (mFOLFOX6 [FOLFOX] or FOLFIRI) demonstrated promising rapid and durable antitumor activity in patients with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC) who have not previously received anti-epidermal growth factor receptor (EGFR) therapy.

巴塞罗那，2024年9月14日/PRNewswire/--强生（纽约证券交易所：JNJ）今天宣布了1b/2期折纸-1研究的新数据，该研究显示RYBREVANT®（amivantamab vmjw）联合化疗（mFOLFOX6[FOLFOX]或FOLFIRI）在先前未接受过抗表皮生长因子受体（EGFR）治疗的RAS/BRAF野生型（WT）转移性结直肠癌（mCRC）患者中显示出有希望的快速持久的抗肿瘤活性。

These data were presented in a mini-oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress.1.

这些数据在欧洲肿瘤内科学会（ESMO）2024年大会上进行了小型口头报告。

'OrigAMI-1 is the first study to show RYBREVANT plus chemotherapy may provide clinically meaningful benefits to patients with metastatic colorectal cancer who have not received any EGFR-targeted treatments as their first or second line of therapy,' said Filippo Pietrantonio, M.D., medical oncologist at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy, and presenting author.* 'Notably, we saw 21 percent of patients proceed to curative intent surgery, showing the promise of RYBREVANT in patients in this setting.'.

意大利米兰Fondazione IRCCS Istituto Nazionale dei Tumori的医学肿瘤学家Filippo Pietrantonio博士说：“OrigAMI-1是第一项显示RYBREVANT加化疗可能为未接受任何EGFR靶向治疗作为第一或第二线治疗的转移性结直肠癌患者提供临床上有意义的益处的研究。”他是本文的作者。*“值得注意的是，我们看到21%的患者进行了治愈性意向手术，这显示了RYBREVANT在这种情况下对患者的前景。”。

In the study, patients receiving RYBREVANT® plus chemotherapy were either in their first (26 percent) or second line (74 percent) of treatment for mCRC and had not been treated with specific anti-EGFR therapies. Patients receiving FOLFOX were oxaliplatin-naïve and patients receiving FOLFIRI were irinotecan-naïve.

在这项研究中，接受RYBREVANT®plus化疗的患者要么处于mCRC治疗的一线（26%），要么处于二线（74%），并且没有接受过特定的抗EGFR治疗。接受FOLFOX的患者未接受奥沙利铂治疗，接受FOLFIRI的患者未接受伊立替康治疗。

Response was assessed by the investigator per RECIST v1.1.** Forty-three patients were treated with RYBREVANT® along with either FOLFOX (20 patients) or FOLFIRI (23 patients). The median follow-up period was 7.3 months for RYBREVANT® plus FOLFOX and RYBREVANT® plus FOLFIRI.1.

研究者根据RECIST v1.1评估了反应。**43名患者接受了RYBREVANT®以及FOLFOX（20名患者）或FOLFIRI（23名患者）的治疗。RYBREVANT®加FOLFOX和RYBREVANT®加FOLFIRI的中位随访期为7.3个月。

Patients treated with RYBREVANT® plus chemotherapy achieved an overall response rate (ORR) of 49 percent (95 percent confidence interval [CI], 33-65), median duration of response of 7.4 months (95 percent CI, 5.6-not estimable [NE]) and median progression-free survival of 7.5 months (95 percent CI, 7.4‒NE).

接受RYBREVANT®联合化疗的患者的总有效率（ORR）为49%（95%置信区间[CI]，33-65），中位反应持续时间为7.4个月（95%CI，5.6-不可估计[NE]）和中位无进展生存期为7.5个月（95%CI，7.4-NE）。

Disease control was observed in 88 percent of patients (95 percent CI, 75-96). Clinically meaningful intrahepatic antitumor activity was observed among patients with liver metastases treated with RYBREVANT® plus chemotherapy, demonstrating a significant reduction in liver tumors (ORR of 53 percent, disease control rate of 93 percent).

88%的患者观察到疾病控制（95%CI，75-96）。在用RYBREVANT®加化疗治疗的肝转移患者中观察到具有临床意义的肝内抗肿瘤活性，表明肝肿瘤显着减少（ORR为53%，疾病控制率为93%）。

Notably, nine (21 percent) patients were able to proceed to curative-intent surgery due to strong antitumor activity.1.

值得注意的是，由于强烈的抗肿瘤活性，9名（21%）患者能够进行治愈性意向手术。

The safety profile of RYBREVANT® plus FOLFOX/FOLFIRI was manageable and consistent with each of the individual components, without any additive toxicity. No new safety signals were observed. The most frequent treatment-emergent adverse events were neutropenia, rash, stomatitis, infusion-related reactions (IRRs) and diarrhea.

RYBREVANT®plus FOLFOX/FOLFIRI的安全性是可控的，并且与每个单独的成分一致，没有任何附加毒性。没有观察到新的安全信号。最常见的治疗紧急不良事件是中性粒细胞减少症，皮疹，口腔炎，输液相关反应（IRR）和腹泻。

All IRRs were Grade 1 or 2 and there were no Grade 3 or higher IRR events reported. Treatment-related discontinuations of RYBREVANT® were 10 percent for RYBREVANT® plus FOLFOX and nine percent for RYBREVANT® plus FOLFIRI.1 .

所有内部收益率均为1级或2级，没有报告3级或更高的内部收益率事件。RYBREVANT®加FOLFOX治疗相关停药率为10%，RYBREVANT®加FOLFIRI治疗相关停药率为9%。

'Confirmation that RYBREVANT has activity beyond lung cancer, given its unique multi-targeted approach in inhibiting EGFR and MET, is a potentially important step forward for patients with EGFR inhibitor-naïve metastatic colorectal cancer,' said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine.

强生创新医学公司实体瘤临床开发副总裁Kiran Patel医学博士说：“鉴于其独特的多靶点抑制EGFR和MET的方法，确认RYBREVANT具有肺癌以外的活性，对于EGFR抑制剂初治转移性结直肠癌患者来说，这是一个潜在的重要步骤。”。

'Colorectal cancer is the third most common cancer globally, representing about 10 percent of all cancer cases and the second leading cause of cancer-related deaths. Our commitment to advancing cancer care drives us to evaluate every possibility to improve patient outcomes, and these findings highlight the potential of RYBREVANT to help even more patients with cancer.'.

结直肠癌是全球第三大常见癌症，约占所有癌症病例的10%，也是癌症相关死亡的第二大原因。我们对推进癌症护理的承诺促使我们评估改善患者预后的每种可能性，这些发现突显了瑞勃列万特帮助更多癌症患者的潜力。”。

Pivotal Phase 3 registration trials evaluating RYBREVANT®-based regimens as first- and second-line treatment in colorectal cancer are planned.

计划进行关键的3期注册试验，评估基于RYBREVANT®的方案作为结直肠癌的一线和二线治疗。

About the OrigAMI-1 Study

关于折纸-1研究

OrigAMI-1 (NCT05379595) is an open-label Phase 1b/2 study assessing the efficacy and safety of RYBREVANT® plus mFOLFOX6 or FOLFIRI in anti-EGFR-naïve RAS/BRAF WT mCRC. Eligible patients were WT for KRAS, NRAS or BRAF genes based on circulating tumor DNA testing. Additionally, patients were required to have no amplification of the ERBB2/HER2 gene.

折纸-1（NCT05379595）是一项开放标签的1b/2期研究，评估RYBREVANT®加mFOLFOX6或FOLFIRI在抗EGFR幼稚RAS/BRAF WT mCRC中的疗效和安全性。根据循环肿瘤DNA测试，符合条件的患者是KRAS，NRAS或BRAF基因的WT。此外，要求患者不扩增ERBB2/HER2基因。

In the RYBREVANT® and chemotherapy cohorts, patients were either treatment-naïve or had received at least one prior line in the metastatic setting (no EGFR inhibitor treatment). The primary endpoint of the combination cohorts was to characterize the safety and confirm the dose of RYBREVANT® plus mFOLFOX6 or FOLFIRI.

在RYBREVANT®和化疗队列中，患者要么未接受治疗，要么在转移环境中至少接受过一次既往治疗（无EGFR抑制剂治疗）。联合队列的主要终点是表征安全性并确认RYBREVANT®加mFOLFOX6或FOLFIRI的剂量。

Response was assessed by the investigator per RECIST v1.1.2.

研究者根据RECIST v1.1.2评估了反应。

About RYBREVANT®

关于[UNK]RYBREVANT®

RYBREVANT® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S., Europe, and in other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.3.

RYBREVANT®（amivantamab vmjw）是一种靶向EGFR并具有免疫细胞导向活性的全人双特异性抗体，已在美国获得批准。S、 。

RYBREVANT® is approved in the U.S., Europe, and in markets around the world in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. .

RYBREVANT®在美国，欧洲和世界各地的市场被批准与化疗（卡铂和培美曲塞）联合用于一线治疗具有EGFR外显子20插入突变的局部晚期或转移性NSCLC的成年患者，如FDA批准的测试所检测到的。。

RYBREVANT® is approved in the U.S. in combination with LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. A marketing authorization application (MAA) and type II extension of indication application were submitted to the European Medicines Agency (EMA) seeking approval of LAZCLUZE™ in combination with RYBREVANT® based on the MARIPOSA study..

RYBREVANT®在美国被批准与LAZCLUZE™（lazertinib）联合用于一线治疗具有EGFR外显子19缺失或L858R替代突变的局部晚期或转移性NSCLC的成年患者，这是通过FDA批准的测试检测到的。根据MARIPOSA研究，向欧洲药品管理局（EMA）提交了上市授权申请（MAA）和II型适应症延期申请，寻求LAZCLUZE™与RYBREVANT®联合使用的批准。。

In November 2023, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for RYBREVANT® in combination with chemotherapy for the treatment of patients with EGFR-mutated NSCLC who progressed on or after osimertinib based on the MARIPOSA-2 study. This indication was approved in Europe in August 2024..

2023年11月，强生公司向美国FDA提交了一份补充生物制剂许可证申请（sBLA），用于RYBREVANT®联合化疗治疗EGFR突变的非小细胞肺癌患者，这些患者根据MARIPOSA-2研究在osimertinib上或之后进展。该适应症于2024年8月在欧洲获得批准。。

In June 2024, Johnson & Johnson submitted a BLA to the U.S. FDA for the subcutaneous formulation of RYBREVANT® in combination with LAZCLUZE™ for all currently approved or submitted indications of intravenous (IV) RYBREVANT® in certain patients with NSCLC. A submission for the extension of the RYBREVANT® marketing authorization (line extension) was also submitted to the EMA seeking approval for this indication. .

2024年6月，强生公司向美国食品和药物管理局提交了一份BLA，用于RYBREVANT®与LAZCLUZE™的皮下制剂，用于某些NSCLC患者目前批准或提交的所有静脉注射（IV）RYBREVANT®适应症。还向EMA提交了RYBREVANT®营销授权扩展（线路扩展）的申请，以寻求对该指示的批准。。

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC§ prefer next-generation sequencing–based strategies over polymerase chain reaction–based approaches for the detection of EGFR exon 20 insertion variants. The NCCN Guidelines include:

针对NSCLC的NCCN肿瘤学临床实践指南（NCCN Guidelines®）更喜欢基于下一代测序的策略，而不是基于聚合酶链反应的方法来检测EGFR外显子20插入变体。

Amivantamab-vmjw (RYBREVANT®) plus lazertinib (LAZCLUZE™) as a Category 1 recommendation for first-line therapy in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.4 †‡Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a Category 1 recommendation for patients with locally advanced or metastatic NCSLC with EGFR exon 19 deletions or exon 21 L858R mutations who experienced disease progression after treatment with osimertinib.4 †‡Amivantamab-vmjw (RYBREVANT®) plus carboplatin and pemetrexed as a Category 1 recommendation for first-line therapy in treatment-naive patients with newly diagnosed advanced or metastatic EGFR exon 20 insertion mutation-positive advanced NSCLC, or as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without immunotherapy and have EGFR exon 20 insertion mutation-positive advanced NSCLC.4 †‡Amivantamab-vmjw (RYBREVANT®) as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without an immunotherapy and have EGFR exon 20 insertion mutation-positive NSCLC.4 †‡In addition to the Phase 1b/2 OrigAMI-1 study, RYBREVANT® is being studied in multiple clinical trials, including:.

Amivantamab vmjw（RYBREVANT®）加lazertinib（LAZCLUZE™）作为EGFR外显子19缺失或外显子21 L858R突变的局部晚期或转移性NSCLC患者一线治疗的1类推荐。4†‡Amivantamab vmjw（RYBREVANT®）加化疗作为局部晚期或转移性NCSLC患者的1类推荐，EGFR外显子19缺失或外显子21 L858R突变在用osimertinib治疗后出现疾病进展。4†‡Amivantamab vmjw（Rybrevantamab®）对于新诊断的晚期或转移性EGFR外显子20插入突变阳性晚期非小细胞肺癌初治患者，加用卡铂和培美曲塞作为一线治疗的1类推荐药物，对于铂类化疗后或铂类化疗后有进展或无免疫治疗且EGFR外显子20插入突变阳性的晚期非小细胞肺癌患者，作为2A类推荐药物。4†‡Amivantamab vmjw（RYBREVANT®）作为2A类推荐，对于在铂类化疗中或在铂类化疗后进行或不进行免疫治疗且EGFR外显子20插入突变阳性NSCLC的患者。4†‡除了1b/2期折纸-1研究外，RYBREVANT®正在多项临床试验中进行研究，包括：。

The Phase 3 MARIPOSA (NCT04487080) study assessing RYBREVANT® in combination with LAZCLUZE™ versus osimertinib and versus LAZCLUZE™ alone in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations.5The Phase 3 MARIPOSA-2 (NCT04988295) study assessing the efficacy of RYBREVANT® (with or without LAZCLUZE™) carboplatin-pemetrexed versus carboplatin-pemetrexed alone in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC after disease progression on or after osimertinib.6The Phase 3 PAPILLON (NCT04538664) study assessing RYBREVANT® in combination with carboplatin-pemetrexed versus chemotherapy alone in the first-line treatment of patients with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.7The Phase 3 PALOMA-3 (NCT05388669) study assessing LAZCLUZE™ with subcutaneous amivantamab compared to intravenous amivantamab in patients with EGFR-mutated advanced or metastatic NSCLC.8The Phase 2 PALOMA-2 (NCT05498428) study assessing subcutaneous amivantamab in patients with advanced or metastatic solid tumors including EGFR-mutated NSCLC.9The Phase 1 PALOMA (NCT04606381) study assessing the feasibility of subcutaneous administration of amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for amivantamab subcutaneous delivery.10The Phase 1 CHRYSALIS (NCT02609776) study evaluating RYBREVANT® in patients with advanced NSCLC.11The Phase 1/1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT® in combination with LAZCLUZE™ and LAZCLUZE™ as a monotherapy in patients with advanced NSCLC with EGFR mutations.12The Phase 1/2 METalmark (NCT05488314) study assessing RYBREVANT® and capmatinib combination therapy in local.

3期MARIPOSA（NCT04487080）研究评估了RYBREVANT®联合LAZCLUZE™与osimertinib以及单独使用LAZCLUZE™一线治疗EGFR ex19del或L858R替代突变的局部晚期或转移性NSCLC患者。5 3期MARIPOSA-2（NCT04988295）研究评估了RYBREVANT®（有或没有LAZCLUZE™）卡铂-培美曲塞与卡铂-培美曲塞单独治疗局部晚期或转移性EGFR ex19del或L858R替代NSCLC患者的疗效在osimertinib.6后，3期PAPILLON（NCT04538664）研究评估了RYBREVANT®联合卡铂-培美曲塞与单独化疗对EGFR外显子20插入突变的晚期或转移性NSCLC患者的一线治疗。7 3期PALOMA-3（NCT05388669）在EGFR突变的晚期或转移性非小细胞肺癌患者中，皮下注射阿米万塔单抗与静脉注射阿米万塔单抗相比，评估LAZCLUZE™的研究。8第2阶段PALOMA-2（NCT05498428）研究评估了晚期或转移性实体瘤患者（包括EGFR突变的非小细胞肺癌）的皮下注射阿米万塔单抗。9第1阶段PALOMA（NCT04606381）研究评估了基于安全性和药代动力学皮下注射阿米万塔单抗的可行性，并确定了阿米万塔单抗皮下给药的剂量，剂量方案和制剂。10第一阶段蛹（NCT02609776）研究评估了晚期患者的RYBREVANT®NSCLC.11 1/1b期CHRYSALIS-2（NCT04077463）研究评估RYBREVANT®联合LAZCLUZE™和LAZCLUZE™作为EGFR突变晚期NSCLC患者的单一疗法。12 1/2期METalmark（NCT05488314）研究评估RYBREVANT®和capmatinib联合治疗局部。

About Colorectal Cancer

关于结直肠癌

Colorectal cancer is the third most common cancer worldwide, accounting for approximately 10 percent of all cancer cases and is the second leading cause of cancer-related deaths worldwide.18 While it predominantly affects older individuals, recent research suggests that colorectal cancer is now being diagnosed in adults under the age of 50 at record rates.19.

结直肠癌是全球第三大最常见的癌症，约占所有癌症病例的10%，是全球癌症相关死亡的第二大原因.18虽然它主要影响老年人，但最近的研究表明，结直肠癌现在正在以创纪录的速度在50岁以下的成年人中被诊断出来.19。

Left-sided colorectal cancer, which represents approximately 65 percent of cases, often has distinct characteristics that influence treatment strategies. Around half of colorectal cancer patients have mutations in the RAS genes, with KRAS being the most common mutation. While tumors with normal RAS and BRAF genes generally respond better to EGFR inhibitors, those with RAS and BRAF mutations – particularly on the left side – are associated with poorer outcomes.20.

左侧结直肠癌约占病例的65%，通常具有影响治疗策略的独特特征。大约一半的结直肠癌患者的RAS基因发生突变，其中KRAS是最常见的突变。虽然具有正常RAS和BRAF基因的肿瘤通常对EGFR抑制剂反应更好，但具有RAS和BRAF突变的肿瘤（尤其是左侧）与较差的结果相关。

IMPORTANT SAFETY INFORMATION3,21

WARNINGS AND PRECAUTIONS

警告和注意事项

Infusion-Related Reactions

输液相关反应

RYBREVANT® can cause infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.

RYBREVANT®可引起输液相关反应（IRR）；IRR的体征和症状包括呼吸困难，潮红，发烧，发冷，恶心，胸部不适，低血压和呕吐。IRR发作的中位时间约为1小时。

RYBREVANT® with LAZCLUZE™

雷布雷万特® 与LAZCLUZE合作™

RYBREVANT® in combination with LAZCLUZE™ can cause infusion-related reactions. In MARIPOSA (n=421), IRRs occurred in 63% of patients treated with RYBREVANT® in combination with LAZCLUZE™, including Grade 3 in 5% and Grade 4 in 1% of patients. The incidence of infusion modifications due to IRR was 54% of patients, and IRRs leading to dose reduction of RYBREVANT® occurred in 0.7% of patients.

RYBREVANT®与LAZCLUZE™联合使用可引起输液相关反应。在MARIPOSA（n=421），使用RYBREVANT®联合LAZCLUZE™治疗的患者中有63%发生IRR，其中3级为5%，4级为1%。由于IRR引起的输液修改发生率为54%，导致RYBREVANT®剂量减少的IRR发生率为0.7%。

Infusion-related reactions leading to permanent discontinuation of RYBREVANT® occurred in 4.5% of patients receiving RYBREVANT® in combination with LAZCLUZE™. .

在接受RYBREVANT®联合LAZCLUZE™治疗的患者中，有4.5%发生了导致RYBREVANT®永久停药的输注相关反应。。

RYBREVANT® with Carboplatin and Pemetrexed

含卡铂和培美曲塞的RYBREVANT®

In PAPILLON (n=151), infusion-related reactions occurred in 42% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, including Grade 3 (1.3%) adverse reactions. The incidence of infusion modifications due to IRR was 40%, and 0.7% of patients permanently discontinued RYBREVANT®. .

在PAPILLON（n=151）中，42%接受RYBREVANT®联合卡铂和培美曲塞治疗的患者发生输注相关反应，包括3级（1.3%）不良反应。IRR引起的输液修改发生率为40%，0.7%的患者永久停用RYBREVANT®。。

RYBREVANT® as a Single Agent

RYBREVANT®作为单一代理

In CHRYSALIS (n=302), IRR occurred in 66% of patients treated with RYBREVANT®. Among patients receiving treatment on Week 1 Day 1, 65% experienced an IRR, while the incidence of IRR was 3.4% with the Day 2 infusion, 0.4% with the Week 2 infusion, and cumulatively 1.1% with subsequent infusions. Of the reported IRRs, 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4.

在蛹（n=302）中，66%接受RYBREVANT®治疗的患者发生IRR。在第1周第1天接受治疗的患者中，65%经历了IRR，而第2天输注的IRR发生率为3.4%，第2周输注的IRR发生率为0.4%，随后输注的IRR发生率为1.1%。在报告的内部收益率中，97%为1-2级，2.2%为3级，0.4%为4级。

The median time to onset was 1 hour (range 0.1 to 18 hours) after start of infusion. The incidence of infusion modifications due to IRR was 62% and 1.3% of patients permanently discontinued RYBREVANT® due to IRR..

开始输注后，中位发病时间为1小时（范围0.1至18小时）。IRR引起的输液修改发生率为62%，1.3%的患者因IRR永久停用RYBREVANT®。。

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 to reduce the risk of infusion-related reactions. Monitor patients for signs and symptoms of infusion reactions during RYBREVANT® infusion in a setting where cardiopulmonary resuscitation medication and equipment are available.

术前服用抗组胺药，退热药和糖皮质激素，并按建议输注RYBREVANT®。在第1周和第2周通过外周线给予RYBREVANT®，以降低输液相关反应的风险。在有心肺复苏药物和设备的情况下，监测患者在RYBREVANT®输液过程中输液反应的体征和症状。

Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity. .

如果怀疑IRR，则中断输注。根据严重程度降低输注速度或永久停用RYBREVANT®。。

Interstitial Lung Disease/Pneumonitis

间质性肺病/肺炎

RYBREVANT® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.

RYBREVANT®可引起严重致命的间质性肺病（ILD）/肺炎。

RYBREVANT® with LAZCLUZE™

雷布雷万特® 与LAZCLUZE合作™

In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients treated with RYBREVANT® in combination with LAZCLUZE™, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case (0.2%) of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT® and LAZCLUZE™ due to ILD/pneumonitis. .

在马里波萨，用RYBREVANT®联合LAZCLUZE™治疗的患者中有3.1%发生ILD/肺炎，其中3级为1.0%，4级为0.2%。有1例致命的ILD/肺炎病例（0.2%），2.9%的患者因ILD/肺炎而永久停用RYBREVANT®和LAZCLUZE™。。

RYBREVANT® with Carboplatin and Pemetrexed

含卡铂和培美曲塞的RYBREVANT®

In PAPILLON, Grade 3 ILD/pneumonitis occurred in 2.6% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, all patients required permanent discontinuation.

在PAPILLON中，2.6%接受RYBREVANT®联合卡铂和培美曲塞治疗的患者发生3级ILD/肺炎，所有患者均需要永久停药。

RYBREVANT® as a Single Agent

RYBREVANT®作为单一代理

In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients treated with RYBREVANT®, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) discontinued RYBREVANT® due to ILD/pneumonitis.

在蛹中，用RYBREVANT®治疗的患者中有3.3%发生ILD/肺炎，0.7%的患者发生3级ILD/肺炎。三名患者（1%）因ILD/肺炎停止服用RYBREVANT®。

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). For patients receiving RYBREVANT® in combination with LAZCLUZE™, immediately withhold both drugs in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

。对于接受RYBREVANT®联合LAZCLUZE™治疗的患者，怀疑患有ILD/肺炎的患者立即停用这两种药物，如果确诊为ILD/肺炎，则永久停用。

For patients receiving RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, immediately withhold RYBREVANT® in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. .

对于接受RYBREVANT®作为单一药物或与卡铂和培美曲塞联合治疗的患者，怀疑患有ILD/肺炎的患者立即停用RYBREVANT®，如果确诊为ILD/肺炎，则永久停用。。

Venous Thromboembolic (VTE) Events with Concomitant Use of RYBREVANT® and LAZCLUZE™

伴随使用RYBREVANT®和LAZCLUZE™的静脉血栓栓塞（VTE）事件

RYBREVANT® in combination with LAZCLUZE™ can cause serious and fatal venous thromboembolic (VTEs) events, including deep vein thrombosis and pulmonary embolism. The majority of these events occurred during the first four months of therapy.

RYBREVANT®联合LAZCLUZE™可导致严重致命的静脉血栓栓塞（VTEs）事件，包括深静脉血栓形成和肺栓塞。这些事件大多数发生在治疗的前四个月。

In MARIPOSA, VTEs occurred in 36% of patients receiving RYBREVANT® in combination with LAZCLUZE™, including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE™; 1% of patients had VTE leading to dose reductions of RYBREVANT®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE™; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE™.

在马里波萨，36%接受RYBREVANT®联合LAZCLUZE™治疗的患者发生VTE，其中3级患者占10%，4级患者占0.5%。在接受抗凝治疗时，1.2%的患者（n=5）发生了研究中的VTE。有两例致命的VTE病例（0.5%），9%的患者VTE导致RYBREVANT®剂量中断，7%的患者VTE导致LAZCLUZE™剂量中断；1%的患者VTE导致RYBREVANT®剂量减少，0.5%的患者VTE导致LAZCLUZE™剂量减少；3.1%的患者VTE导致RYBREVANT®永久停药，1.9%的患者VTE导致LAZCLUZE™永久停药。

The median time to onset of VTEs was 84 days (range: 6 to 777). .

VTE发作的中位时间为84天（范围：6至777）。。

Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended. Monitor for signs and symptoms of VTE events and treat as medically appropriate.

在治疗的前四个月进行预防性抗凝治疗。不建议使用维生素K拮抗剂。。

Withhold RYBREVANT® and LAZCLUZE™ based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT® and LAZCLUZE™ at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT® and continue treatment with LAZCLUZE™ at the same dose level at the discretion of the healthcare provider. .

根据严重程度扣留RYBREVANT®和LAZCLUZE™。一旦开始抗凝治疗，由医疗保健提供者自行决定恢复相同剂量的RYBREVANT®和LAZCLUZE™治疗。尽管进行了治疗性抗凝治疗，但如果VTE复发，则永久停用RYBREVANT®，并由医疗保健提供者自行决定以相同的剂量水平继续使用LAZCLUZE™治疗。。

Dermatologic Adverse Reactions

皮肤科不良反应

RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus, and dry skin.

RYBREVANT®可引起严重皮疹，包括中毒性表皮坏死松解症（TEN）、痤疮样皮炎、瘙痒和皮肤干燥。

RYBREVANT® with LAZCLUZE™

雷布雷万特® 与LAZCLUZE合作™

In MARIPOSA, rash occurred in 86% of patients treated with RYBREVANT® in combination with LAZCLUZE™, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT® and 30% for LAZCLUZE™, rash leading to dose reductions occurred in 23% of patients for RYBREVANT® and 19% for LAZCLUZE™, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT® and 1.7% for LAZCLUZE™..

在马里波萨，使用RYBREVANT®联合LAZCLUZE™治疗的患者中有86%出现皮疹，其中26%的患者出现3级皮疹。皮疹发作的中位时间为14天（范围：1至556天）。导致剂量中断的皮疹发生在37%的RYBREVANT®患者和30%的LAZCLUZE™患者中，导致剂量减少的皮疹发生在23%的RYBREVANT®患者和19%的LAZCLUZE™患者中，导致永久停药的皮疹发生在5%的RYBREVANT®患者和1.7%的LAZCLUZE™患者中。。

RYBREVANT® with Carboplatin and Pemetrexed

含卡铂和培美曲塞的RYBREVANT®

In PAPILLON, rash occurred in 89% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, including Grade 3 (19%) adverse reactions. Rash leading to dose reductions occurred in 19% of patients, and 2% permanently discontinued RYBREVANT® and 1.3% discontinued pemetrexed.

在PAPILLON中，89%接受RYBREVANT®联合卡铂和培美曲塞治疗的患者出现皮疹，包括3级（19%）不良反应。19%的患者出现皮疹导致剂量减少，2%的患者永久停用RYBREVANT®和1.3%的患者停用培美曲塞。

RYBREVANT® as a Single Agent

RYBREVANT®作为单一代理

In CHRYSALIS, rash occurred in 74% of patients treated with RYBREVANT® as a single agent, including Grade 3 rash in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% of patients, and RYBREVANT® was permanently discontinued due to rash in 0.7% of patients. .

在蛹中，使用RYBREVANT®作为单一药物治疗的患者中有74%出现皮疹，其中3.3%的患者出现3级皮疹。皮疹发作的中位时间为14天（范围：1至276天）。5%的患者出现皮疹导致剂量减少，0.7%的患者因皮疹而永久停用RYBREVANT®。。

Toxic epidermal necrolysis occurred in one patient (0.3%) treated with RYBREVANT® as a single agent.

用RYBREVANT®作为单一药物治疗的一名患者（0.3%）发生中毒性表皮坏死松解。

Instruct patients to limit sun exposure during and for 2 months after treatment with RYBREVANT® or LAZCLUZE™ in combination with RYBREVANT®. Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen. Alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream is recommended for dry skin. .

指导患者在使用RYBREVANT®或LAZCLUZE™联合RYBREVANT®治疗期间和治疗后2个月内限制阳光照射。建议患者穿防护服并使用广谱UVA/UVB防晒霜。干性皮肤建议使用不含酒精（例如不含异丙醇、不含乙醇）的润肤霜。。

When initiating RYBREVANT® treatment with or without LAZCLUZE™, administer alcohol-free emollient cream to reduce the risk of dermatologic adverse reactions. Consider prophylactic measures (e.g. use of oral antibiotics) to reduce the risk of dermatologic reactions. If skin reactions develop, start topical corticosteroids and topical and/or oral antibiotics.

在开始使用或不使用LAZCLUZE™的RYBREVANT®治疗时，服用无酒精润肤霜以降低皮肤病不良反应的风险。考虑采取预防措施（例如使用口服抗生素）以降低皮肤病反应的风险。如果出现皮肤反应，开始局部使用皮质类固醇以及局部和/或口服抗生素。

For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT® in combination with LAZCLUZE™, withhold, dose reduce or permanently discontinue both drugs based on severity.

对于3级反应，添加口服类固醇并考虑皮肤科咨询。立即将出现严重皮疹，不典型外观或分布或2周内缺乏改善的患者转诊给皮肤科医生。对于接受RYBREVANT®联合LAZCLUZE™治疗的患者，根据严重程度扣留，减少剂量或永久停用两种药物。

For patients receiving RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT® based on severity. .

对于接受RYBREVANT®作为单一药物或与卡铂和培美曲塞联合治疗的患者，根据严重程度扣留、减少剂量或永久停用RYBREVANT®。。

Ocular Toxicity

眼部毒性

RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus, and uveitis.

RYBREVANT®可引起眼部毒性，包括角膜炎、睑缘炎、干眼症、结膜发红、视力模糊、视力障碍、眼部瘙痒、眼睛瘙痒和葡萄膜炎。

RYBREVANT® with LAZCLUZE™

雷布雷万特® 与LAZCLUZE合作™

In MARIPOSA, ocular toxicity occurred in 16% of patients treated with RYBREVANT® in combination with LAZCLUZE™, including Grade 3 or 4 ocular toxicity in 0.7% of patients. Withhold, reduce the dose, or permanently discontinue RYBREVANT® and continue LAZCLUZE™ based on severity.

在马里波萨，用RYBREVANT®联合LAZCLUZE™治疗的患者中有16%发生眼部毒性，其中0.7%的患者出现3级或4级眼部毒性。扣留、减少剂量或永久停用RYBREVANT®并根据严重程度继续使用LAZCLUZE™治疗。

RYBREVANT® with Carboplatin and Pemetrexed

含卡铂和培美曲塞的RYBREVANT®

In PAPILLON, ocular toxicity including blepharitis, dry eye, conjunctival redness, blurred vision, and eye pruritus occurred in 9%. All events were Grade 1-2.

在PAPILLON中，9%发生眼部毒性，包括睑缘炎，干眼症，结膜发红，视力模糊和眼睛瘙痒。所有事件均为1-2级。

RYBREVANT® as a Single Agent

RYBREVANT®作为单一代理

In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients treated with RYBREVANT®. All events were Grade 1-2.

在蛹中，角膜炎发生率为0.7%，葡萄膜炎发生率为0.3%。所有事件均为1-2级。

Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT® based on severity.

及时将眼部症状新发或恶化的患者转诊给眼科医生。根据严重程度扣留、减少剂量或永久停用RYBREVANT®。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on its mechanism of action and findings from animal models, RYBREVANT® and LAZCLUZE™ can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to the fetus.

根据其作用机制和动物模型的发现，RYBREVANT®和LAZCLUZE™给孕妇服用时会导致胎儿伤害。告知女性生殖潜力对胎儿的潜在风险。

Advise female patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT®.

建议有生殖潜力的女性患者在治疗期间和最后一剂RYBREVANT®后3个月内使用有效的避孕措施。

Advise females of reproductive potential to use effective contraception during treatment with LAZCLUZE™ and for 3 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LAZCLUZE™ and for 3 weeks after the last dose. .

建议有生殖潜力的女性在使用LAZCLUZE™治疗期间和最后一剂后3周内使用有效的避孕措施。建议有生殖潜能的女性伴侣的男性患者在LAZCLUZE™治疗期间和最后一剂后3周内使用有效的避孕措施。。

Adverse Reactions

不良反应

RYBREVANT® with LAZCLUZE™

雷布雷万特® 与LAZCLUZE合作™

For the 421 patients in the MARIPOSA clinical trial who received RYBREVANT® in combination with LAZCLUZE™, the most common adverse reactions (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (RYBREVANT®, 63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), nausea (21%), and ocular toxicity (16%).

。

The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%). .

最常见的3或4级实验室异常（≥2%）是白蛋白降低（8%），钠降低（7%），ALT升高（7%），钾降低（5%），血红蛋白降低（3.8%），AST升高（3.8%），GGT升高（2.6%）和镁升高（2.6%）。。

Serious adverse reactions occurred in 49% of patients who received RYBREVANT® in combination with LAZCLUZE™. Serious adverse reactions occurring in ≥2% of patients included VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and infusion-related reaction (RYBREVANT®) (2.1% each).

49%接受RYBREVANT®联合LAZCLUZE™治疗的患者发生严重不良反应。≥2%的患者发生严重不良反应，包括VTE（11%），肺炎（4%），ILD/肺炎和皮疹（各2.9%），COVID-19（2.4%），胸腔积液和输液相关反应（RYBREVANT®）（各2.1%）。

Fatal adverse reactions occurred in 7% of patients who received RYBREVANT® in combination with LAZCLUZE™ due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each). .

7%接受RYBREVANT®联合LAZCLUZE™治疗的患者因死亡而发生致命不良反应（1.2%）；败血症和呼吸衰竭（各1%）；肺炎，心肌梗塞和猝死（各0.7%）；；和ILD/肺炎，急性呼吸窘迫综合征（ARDS）和心肺骤停（各0.2%）。。

RYBREVANT® with Carboplatin and Pemetrexed

含卡铂和培美曲塞的RYBREVANT®

For the 151 patients in the PAPILLON clinical trial who received RYBREVANT® in combination with carboplatin and pemetrexed, the most common adverse reactions (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), infusion-related reaction (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%).

对于接受RYBREVANT®联合卡铂和培美曲塞治疗的151名PAPILLON临床试验患者，最常见的不良反应（≥20%）是皮疹（90%），指甲毒性（62%），口腔炎（43%），输注相关反应（42%），疲劳（42%），水肿（40%），便秘（40%），食欲下降（36%），恶心（36%），新型冠状病毒肺炎（24%），腹泻（21%）和呕吐（21%）。

The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%). .

最常见的3至4级实验室异常（≥2%）是白蛋白减少（7%），丙氨酸氨基转移酶增加（4%），γ-谷氨酰转移酶增加（4%），钠减少（7%），钾减少（11%），镁减少（2%），白细胞减少（17%），血红蛋白（11%），中性粒细胞（36%），血小板（10%）和淋巴细胞（11%）。。

Serious adverse reactions occurred in 37% of patients who received RYBREVANT® in combination with carboplatin and pemetrexed. Serious adverse reactions in ≥2% of patients included rash, pneumonia, ILD, pulmonary embolism, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified. .

37%接受RYBREVANT®联合卡铂和培美曲塞治疗的患者发生严重不良反应。≥2%的患者出现严重不良反应，包括皮疹、肺炎、ILD、肺栓塞、呕吐和新型冠状病毒肺炎。由于肺炎，脑血管意外，心肺骤停，新型冠状病毒肺炎，败血症和未另行说明的死亡，7例患者（4.6%）发生致命不良反应。。

RYBREVANT® as a Single Agent

RYBREVANT®作为单一代理

For the 129 patients in the CHRYSALIS clinical trial who received RYBREVANT® as a single agent, the most common adverse reactions (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%).

对于接受RYBREVANT®作为单一药物的CHRYSALIS临床试验中的129名患者，最常见的不良反应（≥20%）是皮疹（84%），IRR（64%），甲沟炎（50%），肌肉骨骼疼痛（47%），呼吸困难（37%），恶心（36%），疲劳（33%），水肿（27%），口腔炎（26%），咳嗽（25%），便秘（23%）和呕吐（22%）。

The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%). .

最常见的3至4级实验室异常（≥2%）是淋巴细胞减少（8%），白蛋白减少（8%），磷酸盐减少（8%），钾减少（6%），碱性磷酸酶增加（4.8%），葡萄糖增加（4%），γ-谷氨酰转移酶增加（4%），钠减少（4%）。。

Serious adverse reactions occurred in 30% of patients who received RYBREVANT®. Serious adverse reactions in ≥2% of patients included pulmonary embolism, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death. .

接受RYBREVANT®治疗的患者中有30%发生严重不良反应。≥2%的患者出现严重不良反应，包括肺栓塞，肺炎/ILD，呼吸困难，肌肉骨骼疼痛，肺炎和肌肉无力。2例（1.5%）因肺炎发生致命不良反应，1例（0.8%）因猝死发生致命不良反应。。

LAZCLUZE™ Drug Interactions

LAZCLUZE™药物相互作用

Avoid concomitant use of LAZCLUZE™ with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.

避免将LAZCLUZE™与强效和中度CYP3A4诱导剂同时使用。考虑另一种不可能诱导CYP3A4的伴随药物。

Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.

按照批准的CYP3A4或BCRP底物产品标签中的建议，监测与CYP3A4或BCRP底物相关的不良反应，其中最小的浓度变化可能导致严重的不良反应。

Please read full Prescribing Information for RYBREVANT®.

请阅读RYBREVANT®的完整处方信息。

Please read full Prescribing Information for LAZCLUZE™.

请阅读LAZCLUZE™的完整处方信息。

About Johnson & Johnson

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

在强生公司，我们相信健康就是一切。我们在医疗保健创新方面的优势使我们能够建立一个预防、治疗和治愈复杂疾病的世界，在这个世界上，治疗更加智能，侵入性更小，解决方案更加个性化。通过我们在创新医学和医学技术方面的专业知识，我们拥有独特的优势，可以在今天的所有医疗保健解决方案中进行创新，以实现明天的突破，并深刻影响人类的健康。

Learn more at https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC, and Janssen Biotech, Inc. are Johnson & Johnson companies. .

了解更多信息，请访问https://www.jnj.com/。请访问@JanssenUS和@JNJInnovMed。Janssen Research&Development，LLC和Janssen Biotech，Inc.是强生公司。。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT® (amivantamab-vmjw). The reader is cautioned not to rely on these forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》中定义的“前瞻性声明”，涉及RYBREVANT®（amivantamab vmjw）的产品开发、潜在利益和治疗影响。提醒读者不要依赖这些前瞻性陈述。

These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc.

这些声明基于当前对未来事件的预期。如果基础假设不准确或已知或未知的风险或不确定性出现，实际结果可能与Janssen Research＆Development，LLC，Janssen Biotech，Inc.的预期和预测有很大差异。

and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

和/或强生公司。风险和不确定性包括但不限于：产品研发固有的挑战和不确定性，包括临床成功和获得监管批准的不确定性；商业成功的不确定性；制造困难和延误；竞争，包括竞争对手取得的技术进步、新产品和专利；专利面临的挑战；；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗保健改革；以及医疗保健成本控制的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

有关这些风险、不确定性和其他因素的更多列表和描述，请参见强生公司截至2023年12月31日的10-K表年度报告，包括标题为“关于前瞻性声明的警示说明”和“项目1A”的章节。“风险因素”，以及强生公司随后在10-Q表上的季度报告以及向美国证券交易委员会提交的其他文件中。

*Dr. Filippo Pietrantonio has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

*博士。菲利波·皮特兰托尼奥（FilippoPietrantonio）为强生公司提供咨询、咨询和演讲服务；他没有收到任何媒体工作的报酬。

**RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.

**RECIST（版本1.1）是指实体瘤的反应评估标准，它是衡量实体瘤对治疗反应程度的标准方法，基于肿瘤是否缩小，保持不变或变大。

†See the NCCN Guidelines for detailed recommendations, including other treatment options.

†有关详细建议，包括其他治疗方案，请参阅NCCN指南。

‡The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.

‡NCCN非小细胞肺癌指南为某些应该测试的个体生物标志物提供了建议，并推荐了测试技术，但不认可任何特定的商业生物标志物检测或商业实验室。

§The NCCN Content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way..

§NCCN内容不构成医疗建议，不应代替执业医师寻求专业医疗建议、诊断或治疗。NCCN对其内容、使用或应用不作任何形式的保证，并对其应用或使用不承担任何责任。。

1 Pietrantonio, et al. Amivantamab plus FOLFOX or FOLFIRI in metastatic colorectal cancer: Results from OrigAMI-1, a phase 1b/2 study. 2024 European Society for Medical Oncology. September 14, 2024.2 ClinicalTrials.gov. A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (OrigAMI-1).

1 Pietrantonio等人。Amivantamab加FOLFOX或FOLFIRI治疗转移性结直肠癌：折纸-1的结果，一项1b/2期研究。2024年欧洲肿瘤内科学会。2024年9月14日。ClinicalTrials.gov。对晚期或转移性结直肠癌（OrigAMI-1）参与者的阿米万塔单抗单药治疗以及标准化疗的研究。

https://clinicaltrials.gov/study/NCT05379595?tab=history&a=1. Accessed September 2024.3 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.4 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.9.2024© National Comprehensive Cancer Network, Inc.

https://clinicaltrials.gov/study/NCT05379595?tab=history&a=1.2024年9月访问。RYBREVANT®处方信息。宾夕法尼亚州霍沙姆：Janssen Biotech，Inc.4经NCCN非小细胞肺癌临床实践指南（NCCN Guidelines®）第9.2024版许可引用©National Comprehensive Cancer Network，Inc。

All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed September 2024.5 ClinicalTrials.gov. A Study of Amivantamab and LAZCLUZE™ Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA).

保留所有权利。要查看该指南的最新和完整版本，请在线访问NCCN.org。于2024年9月访问。ClinicalTrials.gov。一项关于阿米万塔单抗和LAZCLUZE™联合治疗与奥西替尼治疗局部晚期或转移性非小细胞肺癌（MARIPOSA）的研究。

Available at: https://www.clinicaltrials.gov/study/NCT04487080. Accessed September 2024.6 ClinicalTrials.gov. A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure (MARIPOSA-2).

网址：https://www.clinicaltrials.gov/study/NCT04487080.。

Available at: https://classic.clinicaltrials.gov/ct2/show/study/NCT04988295. Accessed September 2024. 7 ClinicalTrials.gov. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Ins.

网址：https://classic.clinicaltrials.gov/ct2/show/study/NCT04988295.2024年9月访问。7 ClinicalTrials.gov。一项以表皮生长因子受体（EGFR）外显子20 Ins为特征的晚期或转移性非小细胞肺癌患者联合阿米万塔单抗和卡铂-培美曲塞治疗与卡铂-培美曲塞相比的研究。

Media contact:Suzanne Frostsfrost@its.jnj.com

媒体联系人：苏珊娜Frostsfrost@its.jnj.com

Sarah Freemansfreem21@its.jnj.com

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Investor contact:Raychel Kruperinvestor-relations@its.jnj.com

投资者联系人：RaychelKruperinvestor-relations@its.jnj.com

U.S. Medical Inquiries +1 800 526-7736

U、 美国医疗查询+1 800 526-7736

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SOURCE Johnson & Johnson

来源强生公司