Johnson & Johnson announced that the FDA approved Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

强生公司宣布，FDA批准Rybrevant（amivantamab vmjw）加Lazcluze（lazertinib）用于一线治疗患有表皮生长因子受体（EGFR）外显子19缺失或外显子21 L858R替代突变的局部晚期或转移性非小细胞肺癌（NSCLC）的成年患者。

With this milestone, Rybrevant plus Lazcluze becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC. Rybrevaent is an EGFR- and MET-directed bispecific antibody that engages the immune system, and Lazcluse is a highly selective, brain-penetrant, third-generation oral EGFR TKI.

有了这一里程碑，Rybrevant plus Lazcluze成为第一个也是唯一一个多靶点，无化疗的联合方案，与osimertinib相比，其优势已被批准用于EGFR突变NSCLC患者的一线治疗。Rybrevaent是一种EGFR和MET定向的双特异性抗体，可参与免疫系统，Lazcluse是一种高选择性的脑渗透性第三代口服EGFR TKI。

Rybrevant plus Lazcluze is the only multitargeted regimen targeting both the common EGFR mutations directly..

Rybrevant plus Lazcluze是唯一直接针对常见EGFR突变的多靶点方案。。

“This approval is a crucial development for patients with EGFR-mutated NSCLC, who have faced significant unmet needs for far too long,” said Jill Feldman, lung cancer survivor and co-founder of the EGFR Resisters, a patient advocacy group. “Having witnessed firsthand the remarkable evolution in lung cancer treatment, this profoundly important milestone brings a novel therapeutic approach to patients and their families.

“这一批准对于EGFR突变的非小细胞肺癌患者来说是一个至关重要的发展，他们长期以来面临着严重的未满足需求，”肺癌幸存者兼患者倡导组织EGFR抵抗者联合创始人吉尔·费尔德曼说。“亲眼目睹了肺癌治疗的显着发展，这一极其重要的里程碑为患者及其家人带来了一种新的治疗方法。

I’m thrilled that more patients can now experience the progression-free survival benefits seen in the MARIPOSA study.”.

我很高兴，更多的患者现在可以体验到MARIPOSA研究中所见的无进展生存益处。”。

Lung cancer is the leading cause of cancer mortality worldwide, resulting in 1.8 million deaths each year, with NSCLC accounting for 80 to 85 percent of all cases. Of patients with EGFR-mutated NSCLC, between 25 and 39 percent never receive second-line therapy, due to disease progression and lack of treatment options.

肺癌是全球癌症死亡的主要原因，每年导致180万人死亡，非小细胞肺癌占所有病例的80%至85%。在EGFR突变的NSCLC患者中，由于疾病进展和缺乏治疗选择，25%至39%的患者从未接受过二线治疗。

The five-year survival rate is less than 20 percent for all people with advanced EGFR-mutated NSCLC treated with current standard of care TKI monotherapy. Acquired resistance mechanisms after TKI monotherapy makes subsequent treatment more difficult..

所有晚期EGFR突变NSCLC患者接受目前标准的TKI单药治疗，其五年生存率不到20%。TKI单药治疗后获得性耐药机制使后续治疗更加困难。。

“The unique combination of Rybrevant and Lazcluse demonstrated superior efficacy in the first-line treatment of certain patients with EGFR-mutated advanced NSCLC as shown with the MARIPOSA study,” said Alexander Spira, M.D., Ph.D., FACP, Director, Virginia Cancer Specialists Research Institute, and study investigator.

“如MARIPOSA研究所示，Rybrevant和Lazcluse的独特组合在某些EGFR突变的晚期非小细胞肺癌患者的一线治疗中显示出优越的疗效，”弗吉尼亚州癌症专家研究所所长兼研究调查员Alexander Spira医学博士说。

“Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib. This first-line therapy uses a targeted approach aiming to achieve the best possible patient outcomes while reserving chemotherapy for later stages of treatment when resistance becomes more complex.”.

“患者现在可以选择一种潜在的新的一线护理标准，与osimertinib相比具有显着的临床益处。这种一线治疗采用有针对性的方法，旨在实现最佳的患者预后，同时将化疗保留在治疗后期，当耐药性变得更加复杂时。”。

The FDA approval is based on positive results from the Phase III MARIPOSA study, which showed Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30 percent compared to osimertinib (median progression-free survival [PFS]: 23.7 months versus 16.6 months) in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

FDA的批准是基于III期MARIPOSA研究的阳性结果，该研究显示，在EGFR外显子19缺失或外显子21 L858R替代突变的局部晚期或转移性NSCLC患者的一线治疗中，与osimertinib（中位无进展生存期[PFS]：23.7个月比16.6个月）相比，Rybrevant加Lazcluze可将疾病进展或死亡风险降低30%。

The median duration of response (DOR) was nine months longer with Rybrevant plus Lazcluze versus osimertinib (25.8 months versus 16.7 months), a secondary endpoint of the study..

Rybrevant加Lazcluze与osimertinib（25.8个月比16.7个月）的中位反应持续时间（DOR）延长了9个月，这是该研究的次要终点。。

“Building on more than three decades of oncology innovation, we are uniquely positioned to build best-in-class treatments where survival rates have remained stagnant for years,” said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson. “Rybrevant plus Lazcluze establishes a new benchmark in the advanced first-line setting, and we look forward to bringing this new chemotherapy-free treatment regimen to patients.”.

。“Rybrevant plus Lazcluze在先进的一线环境中建立了一个新的基准，我们期待着为患者提供这种新的无化疗治疗方案。”。

The safety profile of Rybrevant plus Lazcluze was consistent with the profiles of the individual treatments. Venous thromboembolic events (VTE) were observed with the combination. Adverse event (AE) rates were consistent in this arm as compared to other Rybrevant regimens.

Rybrevant plus Lazcluze的安全性与个体治疗的概况一致。观察静脉血栓栓塞事件（VTE）。。

MARIPOSA Publications & Presentations; Results from MARIPOSA were first presented at the European Society of Medical Oncology 2023 Congress and recently published in The New England Journal of Medicine. Results presented at the 2024 American Society of Clinical Oncology annual meeting and published in Annals of Oncology demonstrated the combination’s significant benefit for patients who have at least one high-risk feature, which represents 85 percent of all EGFR-mutated NSCLC cases..

MARIPOSA出版物和演示文稿；MARIPOSA的研究结果首次在2023年欧洲医学肿瘤学会大会上发表，最近发表在《新英格兰医学杂志》上。在2024年美国临床肿瘤学会年会上发表并发表在《肿瘤学年鉴》上的结果表明，该组合对至少有一种高风险特征的患者具有显着益处，占所有EGFR突变NSCLC病例的85%。。

Longer-term follow-up data from MARIPOSA will be presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Congress on Lung Cancer (WCLC) in September.

MARIPOSA的长期随访数据将于9月在国际肺癌研究协会（IASLC）2024年世界肺癌大会（WCLC）上提交。

See- 'Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC': authors: Byoung C. Cho, M.D., Ph.D., Shun Lu, M.D., Ph.D., Enriqueta Felip, M.D., Ph.D., Alexander I. Spira, M.D., Ph.D., Nicolas Girard, M.D., Ph.D., Jong-Seok Lee, M.D., Ph.D., Se-Hoon Lee, M.D., Ph.D., +50, for the MARIPOSA Investigators.

参见“阿米万塔单抗联合拉泽替尼治疗先前未经治疗的EGFR突变晚期非小细胞肺癌”：作者：Byoung C.Cho，M.D.，Ph.D.，Shun Lu，M.D.，Ph.D.，Enriqueta Felip，M.D.，Ph.D.，Alexander I.Spira，M.D.，Ph.D.，Nicolas Girard，M.D.，Ph.D.，Jong Seok Lee，M.D.，Ph.D.，Se Hoon Lee，M.D.，Ph.D.，+50，MARIPOSA调查员。

Published June 26, 2024 DOI: 10.1056/NEJMoa2403614.

发布时间2024年6月26日DOI:10.1056/NEJMoa2403614。

Condition: NSCLC / EGFR

Type: drug

类型：药物