RYBREVANT®（amivantamab-vmjw）联合LAZCLUZE™（lazertinib）在EGFR突变的非小细胞肺癌患者中表现出显著且前所未有的总生存获益，优于奥希替尼-动脉网

RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer

强生等信源发布 2025-03-26 18:08

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可切换为仅中文



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Median overall survival not yet reached with projected improvement of more than one year versus osimertinib

中位总生存期尚未达到，预计比奥希替尼提高一年以上。

RARITAN, N.J.

拉里坦，新泽西州

，

March 26, 2025

2025年3月26日

/PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天公布了三期MARIPOSA研究中癌症治疗的金标准终点总生存期（OS）的结果。与奥希替尼的头对头比较数据显示，RYBREVANT表现良好。

(amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (

(amivantamab-vmjw)联合LAZCLUZE™（lazertinib）显著延长了表皮生长因子受体（EGFR）局部晚期或转移性非小细胞肺癌（NSCLC）患者的一线治疗总生存期（OS）。

EGFR

表皮生长因子受体

) exon 19 deletions (ex19del) or L858R substitution mutations. Median OS is projected to exceed one year beyond the median of three years observed with osimertinib and has not yet been reached. This is the first and only study to show a statistically significant and clinically meaningful OS improvement over osimertinib.

）外显子19缺失（ex19del）或L858R置换突变。预计中位总生存期将超过奥希替尼观察到的三年中位值一年以上，且尚未达到。这是首个也是唯一一个显示出比奥希替尼具有统计学显著性和临床意义总生存期改善的研究。

New compelling data were presented during a proffered paper session at the .

在一场论文报告会上，展示了新的有力数据。

2025 European Lung Cancer Congress (ELCC)

2025年欧洲肺癌大会 (ELCC)

(Abstract #4O).

（摘要编号#4O）。

'The survival curve tells a clear story. RYBREVANT plus LAZCLUZE helps patients live longer, and the benefit keeps growing over time,' said trial investigator Professor Nicolas Girard*, M.D., Ph.D., Head of Medical Oncology, Institut Curie, and Professor of Thoracic Oncology and Respiratory Medicine at the Paris-Saclay University, France.

“生存曲线讲述了一个清晰的故事。RYBREVANT 加上 LAZCLUZE 有助于患者延长生命，而且这种益处随着时间的推移不断增加，”试验研究者尼古拉斯·吉拉德教授（Nicolas Girard），医学博士、哲学博士，法国巴黎-萨克雷大学胸部肿瘤学与呼吸医学教授，同时担任居里研究所肿瘤内科主任，表示。

'We see the gap between the survival curves continue to widen, which is exactly what we want to see in lung cancer treatment to improve outcomes for patients. These results reinforce that we are entering a new era for .

“我们看到生存曲线之间的差距继续扩大，这正是我们希望在肺癌治疗中看到的，以改善患者的预后。这些结果证实我们正在进入一个新时代。

EGFR

表皮生长因子受体

-mutated non-small cell lung cancer; with this evidence in hand, we need to ensure every patient gets the most effective treatment in the first line for the best possible chance at longer survival.'

-突变型非小细胞肺癌；掌握这一证据后，我们需要确保每位患者在一线治疗中获得最有效的治疗，以争取更长生存期的最佳可能。

Unlike progression-free survival (PFS), which tracks the time a treatment keeps a patient's cancer from progressing, OS helps patients understand the impact therapy could have on the ability to live longer from the start of treatment. Extending life expectancy is the most meaningful indicator of a treatment's impact..

与追踪治疗使患者癌症不恶化的持续时间的无进展生存期（PFS）不同，总生存期（OS）帮助患者从治疗开始就了解治疗对其延长生命的可能性。延长预期寿命是衡量治疗效果最有意义的指标。

At a median follow-up of 37.8 months, patients treated with the chemotherapy-free regimen of first-line RYBREVANT

在中位随访37.8个月时，接受无化疗方案的RYBREVANT一线治疗的患者

plus LAZCLUZE™ had a significantly longer OS compared to those receiving osimertinib (hazard ratio [HR], 0.75; 95 percent confidence interval [CI], 0.61-0.92; nominal P<0.005). Median OS for RYBREVANT

接受LAZCLUZE™治疗的患者与接受奥希替尼治疗的患者相比，总生存期（OS）显著更长（风险比[HR]，0.75；95%置信区间[CI]，0.61-0.92；名义P<0.005）。RYBREVANT的中位OS为

plus LAZCLUZE™ has not yet been reached, indicating that survival benefits continue to extend beyond the measured follow-up period (not reached [NR]; 95 percent CI, 42.9-NR). Comparatively, median OS for osimertinib-treated patients was 36.7 months (95 percent CI, 33.4-41.0) and consistent with prior studies with osimertinib.

此外，LAZCLUZE™ 的生存期数据尚未达到，表明其生存获益在测量的随访期之后仍在持续延长（未达到 [NR]；95% 置信区间，42.9-NR）。相比之下，接受奥希替尼治疗的患者中位总生存期为 36.7 个月（95% 置信区间，33.4-41.0），与之前奥希替尼研究的结果一致。

Fifty-six percent of patients treated with RYBREVANT.

百分之五十六的患者使用了RYBREVANT治疗。

and LAZCLUZE™ were alive at three and a half years compared to 44 percent of patients on osimertinib. Projections based on survival data suggest RYBREVANT

和LAZCLUZE™在三年半时的存活率为44%，而接受奥希替尼治疗的患者为44%。基于生存数据的预测表明，RYBREVANT

plus LAZCLUZE™ could extend median OS by at least 12 months compared to osimertinib.

此外，与奥希替尼相比，LAZCLUZE™可能将中位OS延长至少12个月。

The RYBREVANT

RYBREVANT

combination also prolonged multiple secondary endpoints vs osimertinib, including intracranial PFS, intracranial duration of response (DOR) and intracranial overall response rate (ORR). Notably, RYBREVANT

组合疗法相较于奥希替尼还延长了多个次要终点，包括颅内无进展生存期（PFS）、颅内反应持续时间（DOR）和颅内总反应率（ORR）。值得注意的是，RYBREVANT

plus LAZCLUZE™ prolonged time to symptomatic progression (TTSP) – the time from treatment randomization to the onset of lung cancer symptoms – by more than 14 months compared to osimertinib (43.6 months vs 29.3 months; HR, 0.69; 95 percent CI, 0.57–0.83; nominal P<0.001). This is a key patient-centered measure, highlighting how long quality of life can be preserved before lung cancer symptoms emerge..

与奥希替尼相比，LAZCLUZE™将症状进展时间（TTSP）——即从治疗随机分配到肺癌症状出现的时间——延长了14个月以上（43.6个月 vs 29.3个月；HR，0.69；95% CI，0.57–0.83；名义P<0.001）。这是一个以患者为中心的关键指标，突显了在肺癌症状出现之前生活质量可以维持多久。

'Right now, only twenty percent of patients with

'目前，只有百分之二十的患者

EGFR-

表皮生长因子受体-

positive NSCLC survive beyond five years. These MARIPOSA results suggest that RYBREVANT plus LAZCLUZE can change this dire statistic that has been stagnant for far too long,' said Joshua Bauml, M.D., Vice President, Lung Cancer Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. 'This regimen isn't just extending survival, it's offering hope.

阳性非小细胞肺癌患者的五年生存率较低。强生创新医学部肺癌领域副总裁 Joshua Bauml 医学博士表示：“MARIPOSA 研究结果表明，RYBREVANT 联合 LAZCLUZE 有望改变这一长期以来停滞不前的严峻数据。这种治疗方案不仅延长了生存期，还为患者带来了希望。”

By using RYBREVANT plus LAZCLUZE first, we're delaying the need for chemotherapy and giving patients and their families more time.'.

通过首先使用RYBREVANT加LAZCLUZE，我们推迟了对化疗的需求，为患者及其家人争取了更多时间。

The safety profile of RYBREVANT

RYBREVANT的安全性概况

plus LAZCLUZE™ was consistent with the primary analysis, with adverse event (AE) rates comparable to other RYBREVANT

加上LAZCLUZE™与主要分析一致，不良事件（AE）发生率与其他RYBREVANT相当。

regimens. No new safety signals were identified with the additional longer-term follow-up. Most AEs occurred early during RYBREVANT

方案。在额外的长期随访中未发现新的安全信号。大多数不良事件发生在使用RYBREVANT的早期阶段。

and LAZCLUZE™ treatment.

和LAZCLUZE™处理。

RYBREVANT

research findings suggest that implementing prophylactic measures during the first four months of RYBREVANT

研究结果表明，在使用 RYBREVANT 的前四个月实施预防措施

and LAZCLUZE™ treatment may significantly reduce the risk of skin reactions, infusion-related reactions and venous thromboembolic events.

而LAZCLUZE™治疗可能显著降低皮肤反应、输液相关反应和静脉血栓栓塞事件的风险。

2,3,4

2，3，4

The MARIPOSA study

MARIPOSA研究

met its primary endpoint

达到了主要终点

in October 2023, showing a statistically significant and clinically meaningful improvement in PFS compared to osimertinib.

2023年10月，与奥希替尼相比，显示出统计学上显著且具有临床意义的PFS改善。

RYBREVANT

plus LAZCLUZE™ is approved in the United States, Europe and other markets around the world for patients with first-line

plus LAZCLUZE™ 已在美国、欧洲和世界其他市场获批用于一线患者。

EGFR

表皮生长因子受体

-mutated NSCLC. These OS results will be shared with health authorities globally.

-突变的非小细胞肺癌。这些总生存期结果将与全球的卫生当局分享。

About the MARIPOSA Study

关于MARIPOSA研究

MARIPOSA (

蝴蝶 (

NCT04487080

), which enrolled 1,074 patients, is a randomized, Phase 3 study evaluating RYBREVANT

），该研究纳入了1074名患者，是一项随机、三期临床试验，评估RYBREVANT

in combination with LAZCLUZE™ versus osimertinib and versus LAZCLUZE™ alone in first-line treatment of patients with locally advanced or metastatic NSCLC with

与LAZCLUZE™联合使用对比奥希替尼以及对比单独使用LAZCLUZE™，用于局部晚期或转移性非小细胞肺癌（NSCLC）患者的一线治疗。

EGFR

表皮生长因子受体

ex19del or substitution mutations. The primary endpoint of the study is PFS (using RECIST v1.1 guidelines**) as assessed by BICR. Secondary endpoints include OS, ORR, DOR, PFS2 and intracranial PFS.

ex19del或置换突变。研究的主要终点是根据BICR评估的PFS（使用RECIST v1.1指南**）。次要终点包括OS、ORR、DOR、PFS2和颅内PFS。

About RYBREVANT

关于RYBREVANT

RYBREVANT

(amivantamab-vmjw), a fully-human bispecific antibody targeting

(amivantamab-vmjw)，一种全人源双特异性抗体，靶向

EGFR

表皮生长因子受体

and MET with immune cell-directing activity, is approved in the

和具有免疫细胞导向活性的MET一起，已被批准用于

U.S.

美国

，

Europe

欧洲

and other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with

以及全球其他市场，作为单药疗法用于治疗局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。

EGFR

表皮生长因子受体

exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

铂类化疗后或化疗期间疾病进展的、经FDA批准的检测方法检测到的外显子20插入突变。

RYBREVANT

is approved in the

获批于

U.S.

美国

，

Europe

欧洲

and other 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

以及全球其他市场，与化疗（卡铂和培美曲塞）联合用于局部晚期或转移性非小细胞肺癌成人患者的一线治疗。

EGFR

表皮生长因子受体

exon 20 insertion mutations, as detected by an FDA-approved test.

通过FDA批准的检测方法检测到的第20号外显子插入突变。

RYBREVANT

is approved in the

在以下情况下获得批准

U.S.,

美国，

Europe

欧洲

and other markets around the world in combination with LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with

以及全球其他市场与LAZCLUZE™（lazertinib）联合用于一线治疗局部晚期或转移性非小细胞肺癌成人患者，

EGFR

表皮生长因子受体

exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

由FDA批准的检测方法检测到的外显子19缺失或外显子21 L858R置换突变。

RYBREVANT

is approved in the

在以下情况中被批准

U.S.

美国

，

Europe

欧洲

and other markets around the world in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with

以及全球其他市场，联合化疗（卡铂-培美曲塞）用于治疗局部晚期或转移性非小细胞肺癌成人患者，

EGFR

表皮生长因子受体

exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an

外显子19缺失或L858R替代突变，其疾病在接受治疗期间或之后已进展的

EGFR

表皮生长因子受体

TKI.

TKI。

In February 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)

2025年2月，欧洲药品管理局（EMA）人用药品委员会（CHMP）

recommended

推荐的

the approval of SC amivantamab and LAZCLUZE™ in Europe for the first-line treatment of adult patients with advanced NSCLC with

SC amivantamab 和 LAZCLUZE™ 在欧洲获批用于一线治疗携带特定基因变异的晚期非小细胞肺癌成年患者

EGFR

表皮生长因子受体

exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating

外显子19缺失或外显子21 L858R替代突变，以及作为单药治疗具有激活作用的晚期非小细胞肺癌成年患者

EGFR

表皮生长因子受体

exon 20 insertion mutations after failure of platinum-based therapy.

铂类化疗失败后的20号外显子插入突变。

The National Comprehensive Cancer Network

国家综合癌症网络

(NCCN

) Clinical Practice Guidelines in Oncology (NCCN Guidelines

）肿瘤学临床实践指南（NCCN指南

) for NSCLC

非小细胞肺癌 (NSCLC)

段落符号

prefer next-generation sequencing–based strategies over polymerase chain reaction–based approaches for the detection of

优选基于下一代测序的策略，而非基于聚合酶链反应的方法，用于检测

EGFR

表皮生长因子受体

exon 20 insertion variants. The NCCN Guidelines include:

第20外显子插入变异。NCCN指南包括：

Amivantamab-vmjw (RYBREVANT

阿米万单抗-vmjw (RYBREVANT)

) plus lazertinib (LAZCLUZE™) as a Category 1 recommendation for first-line therapy in patients with locally advanced or metastatic NSCLC with

）联合 lazertinib（LAZCLUZE™）作为一线治疗局部晚期或转移性非小细胞肺癌患者的 1 类推荐，适用于具有以下特征的患者：

EGFR

表皮生长因子受体

exon 19 deletions or exon 21 L858R mutations.

外显子19缺失或外显子21 L858R突变。

†‡

Amivantamab-vmjw (RYBREVANT

阿米万他单抗-vmjw（RYBREVANT）

) plus chemotherapy as a Category 1 recommendation for patients with locally advanced or metastatic NSCLC with

）加化疗作为局部晚期或转移性非小细胞肺癌患者的1类推荐，适用于具有以下特征的患者：

EGFR

表皮生长因子受体

exon 19 deletions or exon 21 L858R mutations who experienced disease progression after treatment with osimertinib.

接受奥希替尼治疗后病情进展的19号外显子缺失或21号外显子L858R突变患者。

7†‡

Amivantamab-vmjw (RYBREVANT

Amivantamab-vmjw（RYBREVANT）

) plus chemotherapy as a Category 1 recommendation for first-line therapy in treatment-naive patients with newly diagnosed advanced or metastatic

）加化疗作为一线治疗的1类推荐，用于新诊断的晚期或转移性疾病的初治患者。

EGFR

表皮生长因子受体

exon 20 insertion mutation-positive advanced NSCLC.

第20外显子插入突变阳性的晚期非小细胞肺癌。

7†‡

Amivantamab-vmjw (RYBREVANT

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

）作为第2A类推荐，适用于在铂类化疗后或期间进展的患者，无论是否接受过免疫治疗，并且

EGFR

表皮生长因子受体

exon 20 insertion mutation-positive NSCLC.

20号外显子插入突变阳性的非小细胞肺癌。

7†‡

In addition to the Phase 3 MARIPOSA Study, RYBREVANT

除了3期MARIPOSA研究外，RYBREVANT

is being studied in multiple clinical trials in NSCLC, including:

正在NSCLC的多个临床试验中进行研究，包括：

The Phase 3 MARIPOSA-2 (

第 3 阶段 MARIPOSA-2 (

NCT04988295

) study assessing the efficacy of RYBREVANT

评估RYBREVANT疗效的研究

(with or without LAZCLUZE™) and carboplatin-pemetrexed versus carboplatin-pemetrexed alone in patients with locally advanced or metastatic NSCLC with

（使用或不使用LAZCLUZE™）联合卡铂-培美曲塞与单独使用卡铂-培美曲塞在局部晚期或转移性非小细胞肺癌（NSCLC）患者中

EGFR

表皮生长因子受体

exon 19 deletions or L858R substitution mutations after disease progression on or after osimertinib.

在奥希替尼治疗期间或之后疾病进展后的外显子19缺失或L858R替代突变。

The Phase 3 PAPILLON (

第 3 阶段 PAPILLON (

NCT04538664

) study assessing RYBREVANT

) 评估 RYBREVANT 的研究

in combination with carboplatin-pemetrexed versus chemotherapy alone in the first-line treatment of patients with advanced or metastatic NSCLC with

与卡铂-培美曲塞联合使用对比单独化疗用于晚期或转移性非小细胞肺癌患者的一线治疗

EGFR

表皮生长因子受体

exon 20 insertion mutations.

第20号外显子插入突变。

The Phase 3 PALOMA-3 (

第 3 阶段 PALOMA-3 (

NCT05388669

) study assessing LAZCLUZE™ with subcutaneous (SC) amivantamab compared to RYBREVANT

）评估LAZCLUZE™与皮下（SC）amivantamab相比RYBREVANT的研究

in patients with

在患者中

EGFR

表皮生长因子受体

-mutated advanced or metastatic NSCLC.

-突变的晚期或转移性非小细胞肺癌。

The Phase 2 PALOMA-2 (

第2阶段 PALOMA-2 (

NCT05498428

) study assessing SC amivantamab in patients with advanced or metastatic solid tumors including

) 评估 SC amivantamab 在晚期或转移性实体瘤患者中的研究，包括

EGFR

表皮生长因子受体

-mutated NSCLC.

-突变的非小细胞肺癌。

The Phase 1 PALOMA (

第一阶段的PALOMA (

NCT04606381

) study assessing the feasibility of SC amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for SC amivantamab delivery.

）基于安全性和药代动力学评估SC amivantamab可行性的研究，并确定SC amivantamab递送的剂量、给药方案和制剂。

十二

The Phase 1 CHRYSALIS (

第 1 阶段 CHRYSALIS (

NCT02609776

) study evaluating RYBREVANT

）评估 RYBREVANT 的研究

in patients with advanced NSCLC.

在晚期非小细胞肺癌患者中。

The Phase 1/1b CHRYSALIS-2 (

1/1b期CHRYSALIS-2

NCT04077463

) study evaluating RYBREVANT

）评估 RYBREVANT 的研究

in combination with LAZCLUZE™ and LAZCLUZE™ as a monotherapy in patients with advanced NSCLC with

与LAZCLUZE™联合使用以及LAZCLUZE™单药治疗晚期非小细胞肺癌患者

EGFR

表皮生长因子受体

mutations.

突变。

The Phase 1/2 METalmark (

第1/2阶段METalmark (

NCT05488314

) study assessing RYBREVANT

) 评估 RYBREVANT 的研究

and capmatinib combination therapy in locally advanced or metastatic NSCLC.

和capmatinib联合治疗局部晚期或转移性非小细胞肺癌。

The Phase 1/2 swalloWTail (

第一/二阶段的swalloWTail（

NCT06532032

) study assessing RYBREVANT

) 评估 RYBREVANT 的研究

and docetaxel combination therapy in patients with metastatic NSCLC.

多西他赛联合治疗转移性非小细胞肺癌患者。

The Phase 1/2 PolyDamas (

第1/2阶段PolyDamas (

NCT05908734

) study assessing RYBREVANT

) 评估 RYBREVANT 的研究

and cetrelimab combination therapy in locally advanced or metastatic NSCLC.

和cetrelimab联合疗法用于局部晚期或转移性非小细胞肺癌。

The Phase 2 SKIPPirr study (

第2阶段SKIPPirr研究 (

NCT05663866

) exploring how to decrease the incidence and/or severity of first-dose infusion-related reactions with RYBREVANT

) 探索如何减少首次输注RYBREVANT时的输注相关反应的发生率和/或严重程度

in combination with LAZCLUZE™ in relapsed or refractory

与LAZCLUZE™联合用于复发性或难治性

EGFR

表皮生长因子受体

-mutated advanced or metastatic NSCLC.

- 突变的晚期或转移性非小细胞肺癌。

The Phase 2 COPERNICUS (

第2阶段的COPERNICUS (

NCT06667076

) study combining developments in treatment administration and prophylactic supportive care in representative US patients with common

）研究结合了治疗管理和预防性支持护理的发展，针对具有代表性的美国常见病患者

EGFR

表皮生长因子受体

-mutated NSCLC treated with SC amivantamab in combination with LAZCLUZE™ or chemotherapy.

-经SC amivantamab联合LAZCLUZE™或化疗治疗的NSCLC突变型。

The Phase 2 COCOON (

第二阶段的COCOON (

NCT06120140

) study assessing the effectiveness of a proactive dermatologic management regimen given with first-line RYBREVANT

）评估与一线RYBREVANT一起使用的主动皮肤病管理方案的有效性的研究

and LAZCLUZE™ in patients with

和 LAZCLUZE™ 在患者中

EGFR

表皮生长因子受体

-mutated advanced NSCLC.

-突变型晚期非小细胞肺癌。

For more information, visit:

欲了解更多信息，请访问：

https://www.RYBREVANT.com

。

About

关于

LAZCLUZE

懒簇子

™

In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE™ (marketed as LECLAZA in South Korea). LAZCLUZE™ is an oral, third-generation, brain-penetrant

2018年，Janssen Biotech公司与Yuhan Corporation签订了LAZCLUZE™（在韩国市场销售名称为LECLAZA）的开发许可和合作协议。LAZCLUZE™是一种口服的、第三代、可穿透大脑的

EGFR

表皮生长因子受体

TKI that targets both the T790M mutation and activating

靶向T790M突变和激活的TKI

EGFR

表皮生长因子受体

mutations while sparing wild-type

在不影响野生型的情况下进行突变

EGFR

表皮生长因子受体

. An analysis of the efficacy and safety of LAZCLUZE™ from the Phase 3 LASER301 study was published in

. 第3期LASER301研究中对LAZCLUZE™的有效性和安全性分析已发表在

The Journal of Clinical Oncology

《临床肿瘤学杂志》

in 2023.

2023年。

About Non-Small Cell Lung Cancer

关于非小细胞肺癌

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.

全球范围内，肺癌是最常见的癌症之一，其中非小细胞肺癌占所有肺癌病例的80%至85%。

22,23

22，23

The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.

非小细胞肺癌的主要亚型包括腺癌、鳞状细胞癌和大细胞癌。

Among the most common driver mutations in NSCLC are alterations in

在NSCLC中最常见的驱动突变中，包括以下改变：

EGFR

表皮生长因子受体

, which is a receptor tyrosine kinase controlling cell growth and division.

，它是一种受体酪氨酸激酶，控制细胞生长和分裂。

EGFR

表皮生长因子受体

mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.

在西方腺癌型非小细胞肺癌患者中，10%到15%存在突变，而在亚洲患者中，这一比例为40%到50%。

22,23,26,27,28,29

22、23、26、27、28、29

EGFR

表皮生长因子受体

ex19del or

ex19del 或

EGFR

表皮生长因子受体

L858R mutations are the most common

L858R突变是最常见的

EGFR

表皮生长因子受体

mutations.

突变。

The five-year survival rate for all people with advanced NSCLC and

所有晚期非小细胞肺癌患者的五年生存率

EGFR

表皮生长因子受体

mutations treated with

用...治疗的突变

EGFR

表皮生长因子受体

tyrosine kinase inhibitors (TKIs) is less than 20 percent.

酪氨酸激酶抑制剂（TKIs）的有效率不到20%。

31,32

31，32

EGFR

表皮生长因子受体

exon 20 insertion mutations are the third most prevalent activating

第20号外显子插入突变是第三大最常见的激活突变

EGFR

表皮生长因子受体

mutation.

突变。

Patients with

患者们

EGFR

表皮生长因子受体

exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with

第20外显子插入突变在前线治疗中的实际五年总生存率（OS）为百分之八，比患者的情况更差。

EGFR

表皮生长因子受体

ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.

ex19del 或 L858R 突变，其实际五年总生存率为 19%。

IMPORTANT SAFETY INFORMATION

重要安全信息

6,35

WARNINGS AND PRECAUTIONS

警告和注意事项

Infusion-Related Reactions

与输注相关的反应

RYBREVANT

can cause infusion-related reactions (IRR) including anaphylaxis; 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.

可能引起输液相关反应 (IRR)，包括过敏反应；IRR 的体征和症状包括呼吸困难、潮红、发热、寒战、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™

使用LAZCLUZE™

RYBREVANT

in combination with LAZCLUZE™ can cause infusion-related reactions. In MARIPOSA (n=421), IRRs occurred in 63% of patients treated with RYBREVANT

与LAZCLUZE™联合使用可能引起输注相关反应。在MARIPOSA（n=421）中，63%接受RYBREVANT治疗的患者发生了IRR。

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

与LAZCLUZE™联合使用时，包括5%的患者出现3级和1%的患者出现4级反应。因IRR导致的输注调整发生率为54%，而因IRR导致RYBREVANT剂量减少的情况为。

occurred in 0.7% of patients. Infusion-related reactions leading to permanent discontinuation of RYBREVANT

发生在0.7%的患者中。导致永久停用RYBREVANT的输液相关反应

occurred in 4.5% of patients receiving RYBREVANT

接受RYBREVANT治疗的患者中有4.5%发生了该情况

in combination with LAZCLUZE™.

与LAZCLUZE™结合使用。

RYBREVANT

with Carboplatin and Pemetrexed

与卡铂和培美曲塞一起

Based on the pooled safety population (n=281), IRR occurred in 50% of patients treated with RYBREVANT

基于汇总的安全性人群（n=281），50%接受RYBREVANT治疗的患者发生了IRR。

in combination with carboplatin and pemetrexed, including Grade 3 (3.2%) adverse reactions. The incidence of infusion modifications due to IRR was 46%, and 2.8% of patients permanently discontinued RYBREVANT

与卡铂和培美曲塞联合使用时，包括3级（3.2%）不良反应。因IRR导致的输注调整发生率为46%，2.8%的患者永久停用了RYBREVANT。

due to IRR.

由于内部收益率（IRR）。

RYBREVANT

as a Single Agent

作为单一代理

In CHRYSALIS (n=302), IRR occurred in 66% of patients treated with RYBREVANT

在CHRYSALIS（n=302）中，66%接受RYBREVANT治疗的患者发生了IRR。

. 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天输注时IRR的发生率为3.4%，第2周输注时为0.4%，随后的输注中累计发生率为1.1%。在报告的IRRs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.

输注开始后，中位发病时间为1小时（范围0.1至18小时）。因IRR导致的输注调整发生率为62%，1.3%的患者永久停用RYBREVANT。

due to IRR.

由于内部收益率（IRR）。

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT

预先用抗组胺药、退烧药和糖皮质激素进行药物治疗，并输注RYBREVANT。

as recommended. Administer RYBREVANT

根据推荐。给予 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

通过第1周和第2周的外周线路给药，以减少输注相关反应的风险。在使用RYBREVANT期间，监测患者是否出现输注反应的体征和症状。

infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT

在配备心肺复苏药物和设备的环境下进行输注。如果怀疑出现IRR，应中断输注。降低输注速率或永久停止使用RYBREVANT。

based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT

基于严重程度。如果发生过敏反应，永久停止使用 RYBREVANT。

。

Interstitial Lung Disease/Pneumonitis

间质性肺病/肺炎

RYBREVANT

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

可能导致严重和致命的间质性肺病 (ILD)/肺炎。

RYBREVANT

with LAZCLUZE™

使用LAZCLUZE™

In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients treated with RYBREVANT

在MARIPOSA中，接受RYBREVANT治疗的患者中有3.1%发生ILD/肺炎。

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

与LAZCLUZE™联合使用时，包括1.0%的患者出现3级和0.2%的患者出现4级症状。有一例致命的ILD/肺炎病例（0.2%），2.9%的患者永久停用了RYBREVANT。

and LAZCLUZE™ due to ILD/pneumonitis.

由于ILD/肺炎，LAZCLUZE™。

RYBREVANT

with Carboplatin and Pemetrexed

与卡铂和培美曲塞

Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% treated with RYBREVANT

基于汇总的安全性人群，2.1%接受RYBREVANT治疗的患者发生了ILD/肺炎。

in combination with carboplatin and pemetrexed with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT

与卡铂和培美曲塞联合使用时，1.8%的患者出现3级ILD/肺炎。2.1%的患者停止使用RYBREVANT。

due to ILD/pneumonitis.

由于ILD/肺炎。

RYBREVANT

as a Single Agent

作为单一药剂

In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients treated with RYBREVANT

在CHRYSALIS研究中，接受RYBREVANT治疗的患者中有3.3%发生ILD/肺炎。

, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT

，有0.7%的患者出现3级ILD/肺炎。3名患者（1%）永久停用RYBREVANT。

due to ILD/pneumonitis.

由于ILD/肺炎。

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). For patients receiving RYBREVANT

监测患者是否有提示ILD/肺炎的新发或恶化症状（如呼吸困难、咳嗽、发热）。对于接受RYBREVANT治疗的患者。

in combination with LAZCLUZE™, immediately withhold both drugs in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. For patients receiving RYBREVANT

与LAZCLUZE™联合使用时，如果患者疑似出现ILD/肺炎，应立即停用两种药物，并在确认ILD/肺炎时永久停用。对于接受RYBREVANT的患者，

as a single agent or in combination with carboplatin and pemetrexed, immediately withhold RYBREVANT

作为单一药物或与卡铂和培美曲塞联合使用时，立即停用RYBREVANT。

in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

在疑似ILD/肺炎患者中，并在确认ILD/肺炎时永久停用。

Venous Thromboembolic (VTE) Events with Concomitant Use of RYBREVANT

静脉血栓栓塞（VTE）事件与RYBREVANT的合并使用

and LAZCLUZE™

和 LAZCLUZE™

RYBREVANT

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

与LAZCLUZE™联合使用可能导致严重甚至致命的静脉血栓栓塞（VTE）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内。

In MARIPOSA, VTEs occurred in 36% of patients receiving RYBREVANT

在MARIPOSA中，接受RYBREVANT治疗的患者中有36%发生了VTE。

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

与LAZCLUZE™联用时，包括10%的患者出现3级和0.5%的患者出现4级反应。在接受抗凝治疗期间，1.2%的患者（n=5）发生了研究中的静脉血栓栓塞事件（VTEs）。有两例致命的VTE病例（0.5%），9%的患者因VTE导致RYBREVANT剂量中断。

, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE™; 1% of patients had VTE leading to dose reductions of RYBREVANT

，7%的患者因VTE导致LAZCLUZE™剂量中断；1%的患者因VTE导致RYBREVANT剂量减少。

, 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

，0.5%的患者因VTE导致LAZCLUZE™剂量减少；3.1%的患者因VTE导致永久停用RYBREVANT。

, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE™. The median time to onset of VTEs was 84 days (range: 6 to 777).

，1.9%的患者因静脉血栓栓塞导致永久停用LAZCLUZE™。静脉血栓栓塞的中位发病时间为84天（范围：6至777天）。

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.

在治疗的前四个月给予预防性抗凝治疗。不建议使用维生素K拮抗剂。监测VTE事件的体征和症状，并根据医学需要进行治疗。

Withhold RYBREVANT

保留RYBREVANT

and LAZCLUZE™ based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT

根据严重程度使用LAZCLUZE™。一旦开始抗凝治疗，恢复使用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

并在医生自行决定下，使用相同剂量的LAZCLUZE™。如果在治疗性抗凝的情况下仍出现VTE复发，则永久停用RYBREVANT。

and continue treatment with LAZCLUZE™ at the same dose level at the discretion of the healthcare provider.

并根据医疗保健提供者的判断，继续以相同剂量水平使用LAZCLUZE™进行治疗。

Dermatologic Adverse Reactions

皮肤病学不良反应

RYBREVANT

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

可能导致严重皮疹，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™

使用LAZCLUZE™

In MARIPOSA, rash occurred in 86% of patients treated with RYBREVANT

在MARIPOSA研究中，接受RYBREVANT治疗的患者中有86%出现了皮疹。

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

与LAZCLUZE™联合使用时，包括26%的患者出现3级症状。皮疹发作的中位时间为14天（范围：1至556天）。因皮疹导致剂量中断的患者占37%，涉及RYBREVANT。

and 30% for LAZCLUZE™, rash leading to dose reductions occurred in 23% of patients for RYBREVANT

对于LAZCLUZE™，30%的患者出现皮疹导致剂量减少，而对于RYBREVANT，这一比例为23%。

and 19% for LAZCLUZE™, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT

LAZCLUZE™为19%，而因皮疹导致永久停药的患者占RYBREVANT的5%。

and 1.7% for LAZCLUZE™.

LAZCLUZE™为1.7%。

RYBREVANT

with Carboplatin and Pemetrexed

与卡铂和培美曲塞一起

Based on the pooled safety population, rash occurred in 82% of patients treated with RYBREVANT

基于汇总的安全性人群，82%接受RYBREVANT治疗的患者出现皮疹。

in combination with carboplatin and pemetrexed, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT

与卡铂和培美曲塞联合使用时，包括3级（15%）不良反应。14%的患者出现皮疹导致剂量减少，2.5%的患者永久停用RYBREVANT。

and 3.1% discontinued pemetrexed.

3.1%的患者停止了培美曲塞的使用。

RYBREVANT

as a Single Agent

作为单一代理

In CHRYSALIS, rash occurred in 74% of patients treated with RYBREVANT

在CHRYSALIS研究中，74%接受RYBREVANT治疗的患者出现了皮疹。

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

作为单一药物，包括3.3%的患者出现3级皮疹。皮疹的中位发病时间为14天（范围：1至276天）。导致剂量减少的皮疹发生在5%的患者中，并且RYBREVANT

was permanently discontinued due to rash in 0.7% of patients.

因皮疹在0.7%的患者中永久停用。

Toxic epidermal necrolysis occurred in one patient (0.3%) treated with RYBREVANT

一名接受RYBREVANT治疗的患者（0.3%）发生了中毒性表皮坏死松解症。

as a single agent.

作为单一药剂。

Instruct patients to limit sun exposure during and for 2 months after treatment with RYBREVANT

指示患者在使用 RYBREVANT 治疗期间及治疗后 2 个月内限制日晒。

or LAZCLUZE™ in combination with RYBREVANT

或 LAZCLUZE™ 与 RYBREVANT 联合使用

. 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.

. 建议患者穿着防护服并使用广谱UVA/UVB防晒霜。对于干燥皮肤，推荐使用无酒精（如无异丙醇、无乙醇）的润肤霜。

When initiating RYBREVANT

开始使用RYBREVANT时

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.

使用或不使用LAZCLUZE™进行治疗时，涂抹不含酒精的润肤霜以降低皮肤不良反应的风险。考虑采取预防措施（例如，使用口服抗生素）以减少皮肤反应的风险。如果出现皮肤反应，开始使用局部皮质类固醇和局部和/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.

对于3级反应，加用口服类固醇并考虑皮肤科会诊。迅速将出现严重皮疹、非典型外观或分布、或2周内未见改善的患者转诊给皮肤科医生。对于接受RYBREVANT治疗的患者。

in combination with LAZCLUZE™, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT

与LAZCLUZE™联合使用时，根据严重程度，暂停、减少剂量或永久停用两种药物。对于接受RYBREVANT的患者，

as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT

作为单一药物或与卡铂和培美曲塞联合使用时，应暂停、减量或永久停用RYBREVANT。

based on severity.

基于严重程度。

Ocular Toxicity

眼毒性

RYBREVANT

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

可能导致眼部毒性，包括角膜炎、睑缘炎、干眼症状、结膜充血、视力模糊、视力受损、眼部瘙痒、眼瘙痒和葡萄膜炎。

RYBREVANT

with LAZCLUZE™

使用LAZCLUZE™

In MARIPOSA, ocular toxicity occurred in 16% of patients treated with RYBREVANT

在MARIPOSA中，接受RYBREVANT治疗的患者中有16%发生了眼部毒性。

in combination with LAZCLUZE™, including Grade 3 or 4 ocular toxicity in 0.7% of patients. Withhold, reduce the dose, or permanently discontinue RYBREVANT

与LAZCLUZE™联合使用时，包括0.7%的患者出现3级或4级眼部毒性。暂停、减少剂量或永久停用RYBREVANT。

and continue LAZCLUZE™ based on severity.

并根据严重程度继续使用LAZCLUZE™。

RYBREVANT

with Carboplatin and Pemetrexed

使用卡铂和培美曲塞

Based on the pooled safety population, ocular toxicity occurred in 16% of patients treated with RYBREVANT

基于汇总的安全人群，16%接受RYBREVANT治疗的患者发生了眼部毒性。

in combination with carboplatin and pemetrexed. All events were Grade 1 or 2.

与卡铂和培美曲塞联合使用。所有事件均为 1 级或 2 级。

RYBREVANT

瑞普利单抗

as a Single Agent

作为单一药剂

In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients treated with RYBREVANT

在CHRYSALIS研究中，接受RYBREVANT治疗的患者中有0.7%出现角膜炎，0.3%出现葡萄膜炎。

. All events were Grade 1-2.

所有事件均为1-2级。

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

立即转诊出现新发或恶化的眼部症状的患者给眼科医生。暂停、减少剂量或永久停用 RYBREVANT。

based on severity.

基于严重程度。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on its mechanism of action and findings from animal models, RYBREVANT

基于其作用机制和动物模型的研究结果，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.

LAZCLUZE™ 在给孕妇使用时可能会对胎儿造成伤害。请告知有生殖潜力的女性对胎儿的潜在风险。

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

建议有生育潜力的女性患者在治疗期间及最后一次服用RYBREVANT后3个月内使用有效避孕措施。

。

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..

建议有生育潜力的女性在使用LAZCLUZE™治疗期间以及最后一剂后3周内使用有效的避孕措施。建议有生育潜力女性伴侣的男性患者在使用LAZCLUZE™治疗期间以及最后一剂后3周内使用有效的避孕措施。

Adverse Reactions

不良反应

RYBREVANT

with LAZCLUZE™

使用LAZCLUZE™

For the 421 patients in the MARIPOSA clinical trial who received RYBREVANT

在MARIPOSA临床试验中接受RYBREVANT治疗的421名患者

in combination with LAZCLUZE™, the most common adverse reactions (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (RYBREVANT

与LAZCLUZE™联合使用时，最常见的不良反应（≥20%）为皮疹（86%）、指甲毒性（71%）、输液相关反应（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%)..

，63%）、肌肉骨骼疼痛（47%）、口腔炎（43%）、水肿（43%）、静脉血栓栓塞（36%）、感觉异常（35%）、疲劳（32%）、腹泻（31%）、便秘（29%）、新冠病毒感染（26%）、出血（25%）、皮肤干燥（25%）、食欲减退（24%）、瘙痒（24%）、恶心（21%）和眼部毒性（16%）。最常见的 3 或 4 级实验室异常（≥2%）为白蛋白降低（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

接受RYBREVANT治疗的患者中有49%发生了严重不良反应。

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

与LAZCLUZE™联合使用时，≥2%的患者中发生的严重不良反应包括静脉血栓栓塞（11%）、肺炎（4%）、间质性肺病/肺炎和皮疹（各2.9%）、新冠肺炎（2.4%）、胸腔积液和输液相关反应（RYBREVANT）。

) (2.1% each). Fatal adverse reactions occurred in 7% of patients who received RYBREVANT

)（各占2.1%）。接受RYBREVANT治疗的患者中有7%发生了致命的不良反应。

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)..

与LAZCLUZE™联合使用时，由于未明确指定的死亡原因（1.2%）；败血症和呼吸衰竭（各1%）；肺炎、心肌梗死和猝死（各0.7%）；脑梗死、肺栓塞（PE）和COVID-19感染（各0.5%）；以及间质性肺病/肺炎、急性呼吸窘迫综合征（ARDS）和心肺骤停（各0.2%）。

RYBREVANT

瑞普替尼

with Carboplatin and Pemetrexed

与卡铂和培美曲塞一起

For the 130 patients in the MARIPOSA-2 clinical trial who received RYBREVANT

在MARIPOSA-2临床试验中接受RYBREVANT治疗的130名患者中

in combination with carboplatin and pemetrexed, the most common adverse reactions (≥20%) were rash (72%), infusion-related reactions (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%).

与卡铂和培美曲塞联合使用时，最常见的不良反应（≥20%）为皮疹（72%）、输液相关反应（59%）、疲劳（51%）、指甲毒性（45%）、恶心（45%）、便秘（39%）、水肿（36%）、口腔炎（35%）、食欲减退（31%）、肌肉骨骼疼痛（30%）、呕吐（25%）以及新冠肺炎（21%）。

The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%)..

最常见的 3 至 4 级实验室异常（≥2%）为中性粒细胞减少 (49%)、白细胞减少 (42%)、淋巴细胞减少 (28%)、血小板减少 (17%)、血红蛋白减少 (12%)、钾减少 (11%)、钠减少 (11%)、丙氨酸氨基转移酶升高 (3.9%)、白蛋白减少 (3.8%) 和 γ-谷氨酰转移酶升高 (3.1%)。

In MARIPOSA-2, serious adverse reactions occurred in 32% of patients who received RYBREVANT

在MARIPOSA-2中，32%接受RYBREVANT治疗的患者发生了严重不良反应。

in combination with carboplatin and pemetrexed. Serious adverse reactions in >2% of patients included dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and pulmonary embolism (2.3%). Fatal adverse reactions occurred in 2.3% of patients who received RYBREVANT

与卡铂和培美曲塞联合使用。超过2%的患者出现严重不良反应，包括呼吸困难（3.1%）、血小板减少（3.1%）、败血症（2.3%）和肺栓塞（2.3%）。接受RYBREVANT治疗的患者中有2.3%发生致命不良反应。

in combination with carboplatin and pemetrexed; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).

与卡铂和培美曲塞联合使用时，这些包括呼吸衰竭、败血症和心室颤动（各0.8%）。

For the 151 patients in the PAPILLON clinical trial who received RYBREVANT

在PAPILLON临床试验中，接受RYBREVANT治疗的151名患者

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%).

与卡铂和培美曲塞联合使用时，最常见的不良反应（≥20%）为皮疹（90%）、指甲毒性（62%）、口腔炎（43%）、输液相关反应（42%）、疲劳（42%）、水肿（40%）、便秘（40%）、食欲减退（36%）、恶心（36%）、新冠肺炎（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%）为白蛋白降低（7%）、丙氨酸氨基转移酶升高（4%）、γ-谷氨酰转移酶升高（4%）、钠降低（7%）、钾降低（11%）、镁降低（2%）、白细胞减少（17%）、血红蛋白减少（11%）、中性粒细胞减少（36%）、血小板减少（10%）和淋巴细胞减少（11%）。

In PAPILLON, serious adverse reactions occurred in 37% of patients who received RYBREVANT

在PAPILLON中，接受RYBREVANT治疗的患者中有37%发生了严重不良反应。

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..

与卡铂和培美曲塞联合使用。≥2%的患者中出现的严重不良反应包括皮疹、肺炎、间质性肺病、肺栓塞、呕吐和新冠肺炎。7例患者（4.6%）发生致死性不良反应，原因包括肺炎、脑血管意外、心肺骤停、新冠肺炎、败血症以及未明确的死亡。

RYBREVANT

as a Single Agent

作为单一药剂

For the 129 patients in the CHRYSALIS clinical trial who received RYBREVANT

对于在CHRYSALIS临床试验中接受RYBREVANT治疗的129名患者

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%). 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%)..

作为一种单一药物，最常见的不良反应（≥20%）为皮疹（84%）、IRR（64%）、甲周炎（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%）。最常见的3至4级实验室异常（≥2%）为淋巴细胞减少（8%）、白蛋白减少（8%）、磷酸盐减少（8%）、钾减少（6%）、碱性磷酸酶升高（4.8%）、葡萄糖升高（4%）、γ-谷氨酰转移酶升高（4%）和钠减少（4%）。

Serious adverse reactions occurred in 30% of patients who received RYBREVANT

接受RYBREVANT治疗的患者中有30%发生了严重不良反应。

. 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.

≥2%的患者中出现的严重不良反应包括肺栓塞、肺炎/间质性肺病、呼吸困难、肌肉骨骼疼痛、肺炎和肌肉无力。2例患者（1.5%）因肺炎导致致命不良反应，1例患者（0.8%）因猝死导致致命不良反应。

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.

避免同时使用LAZCLUZE™与强效和中效CYP3A4诱导剂。考虑选择一种不会诱导CYP3A4的替代药物同时使用。

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.

监测与CYP3A4或BCRP底物相关的不良反应，因为即使是微小的浓度变化也可能导致严重的不良反应，这是CYP3A4或BCRP底物的批准产品标签中推荐的。

Please read full

请阅读全文

Prescribing Information

处方信息

for RYBREVANT

针对RYBREVANT

。

Please read full

请阅读全文

Prescribing Information

处方信息

for LAZCLUZE™.

适用于LAZCLUZE™。

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，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构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且侵入性更小，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今全面的医疗保健解决方案领域进行创新，以实现明天的突破，并对人类健康产生深远影响。

Learn more at .

了解更多，请访问。

https://www.jnj.com

or at

或在

http://www.innovativemedicine.jnj.com/

. Follow us at

关注我们

@JNJInnovMed

. Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen-Cilag, S.A. are Johnson & Johnson companies.

杨森-西拉格国际公司、杨森研究与发展有限责任公司、杨森生物技术公司、杨森全球服务有限责任公司和杨森-西拉格股份有限公司均为强生公司旗下企业。

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

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的关于产品开发以及RYBREVANT潜在益处和治疗影响的“前瞻性声明”。

and LAZCLUZE™. The reader is cautioned not to rely on these forward-looking statements. 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-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A.

和LAZCLUZE™。读者应注意不要依赖这些前瞻性声明。这些声明基于对未来事件的当前预期。如果基本假设被证明不准确或已知或未知的风险或不确定性成为现实，实际结果可能与杨森-西拉格国际公司、杨森研究与发展有限责任公司、杨森生物技术公司、杨森全球服务有限责任公司、杨森-西拉格股份有限公司的预期和预测有重大差异。

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：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性以及获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手推出的新产品和获得的专利；专利面临的挑战；产品功效或安全性问题导致的产品召回或监管行动；医疗卫生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，包括全球医疗改革；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, 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.

这些风险、不确定性和其他因素的进一步列表和描述，请参见强生公司最近的Form 10-K年度报告，包括标题为“关于前瞻性陈述的警示说明”和“项目1A. 风险因素”的部分，以及强生公司随后的Form 10-Q季度报告和其他提交给证券交易委员会的文件。

Copies of these filings are available online at .

这些文件的副本可在线获取，网址为。

http://www.sec.gov

，

http://www.jnj.com

, or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. .

，或者根据强生公司的要求。杨森-西拉格国际公司、杨森研发有限责任公司、杨森生物科技公司、杨森全球服务有限责任公司、杨森-西拉格股份有限公司以及强生公司均不承担因新信息、未来事件或发展而更新任何前瞻性声明的义务。

###

*Nicolas Girard, M.D., Ph.D., has served as a consultant to Johnson & Johnson; he has not been paid for any media work.

尼古拉斯·吉拉德，医学博士、哲学博士，曾担任强生公司的顾问；他未因任何媒体工作获得报酬。

**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（1.1版）指实体瘤疗效评价标准，这是一种衡量实体瘤对治疗反应的标准方法，依据肿瘤是缩小、保持不变还是增大来评估。

†

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非小细胞肺癌指南提供了应检测的某些个体生物标志物的建议，并推荐了检测技术，但不支持任何特定的商业可用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，不应替代由有执照的从业者提供的专业医疗建议、诊断或治疗。NCCN对其内容、使用或应用不作任何形式的保证，并拒绝承担因使用或应用其内容而产生的任何责任。

_________________________

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RYBREVANT

Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

处方信息。宾夕法尼亚州霍舍姆：杨森生物技术公司。

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines

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一项关于Amivantamab和LAZCLUZE™联合铂类化疗与单用铂类化疗在表皮生长因子受体（EGFR）突变的局部晚期或转移性非小细胞肺癌患者中奥希替尼治疗失败后的研究（MARIPOSA-2）。可访问：https://classic.clinicaltrials.gov/ct2/show/study/NCT04988295。

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一项关于LAZCLUZE™与皮下注射Amivantamab对比静脉注射Amivantamab在表皮生长因子受体（EGFR）突变的晚期或转移性非小细胞肺癌（NSCLC）患者中的研究（PALOMA-3）。https://clinicaltrials.gov/ct2/show/NCT05388669。访问时间：2025年3月。

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十二

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世界卫生组织。癌症。

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美国癌症协会。什么是肺癌？

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LAZCLUZE™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

LAZCLUZE™ 处方信息。宾夕法尼亚州霍舍姆：杨森生物技术公司。

Media contact:

媒体联系人：

Investor contact:

投资者联系方式：

Oncology Media Relations

肿瘤学媒体关系

Lauren Johnson

劳伦·约翰逊

oncology_media_relations@its.jnj.com

肿瘤学媒体关系@its.jnj.com

investor-relations@its.jnj.com

投资者关系@its.jnj.com

U.S. Medical Inquiries:

美国医学咨询：

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SOURCE Johnson & Johnson

来源：强生公司

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