Amivantamab plus lazertinib versus osimertinib as first-line treatment in EGFR-mutated advanced non-small cell lung cancer: MARIPOSA Asian subset
- PMID: 40300278
- DOI: 10.1016/j.lungcan.2025.108496
Amivantamab plus lazertinib versus osimertinib as first-line treatment in EGFR-mutated advanced non-small cell lung cancer: MARIPOSA Asian subset
Abstract
Introduction: The incidence of epidermal growth factor receptor (EGFR) mutations is higher among Asian patients with advanced non-small cell lung cancer than the general advanced non-small cell lung cancer population. We evaluated the efficacy and safety of amivantamab in combination with lazertinib versus osimertinib in Asian participants from the phase 3 MARIPOSA study who had treatment-naïve advanced non-small cell lung cancer with common EGFR mutations.
Methods: Participants were randomized 2:2:1 to receive amivantamab-lazertinib, osimertinib alone, or lazertinib alone. The primary endpoint was progression-free survival based on blinded independent central review per RECIST v1.1. Secondary endpoints included overall survival, objective response rate, duration of response, and safety. Exploratory endpoints included extracranial progression-free survival and post-progression outcomes.
Results: Of 1074 randomized participants, 629 were Asian, with 250 and 251 randomized to the amivantamab-lazertinib and osimertinib arms, respectively. Among Asian participants, at a median follow-up of 22.5 months, amivantamab-lazertinib showed a 35 % reduction in the risk of disease progression or death versus osimertinib (hazard ratio, 0.65; P < 0.001). Consistent with the overall population, median progression-free survival was 27.5 and 18.3 months in the amivantamab-lazertinib and osimertinib arms, respectively. The objective response rate was 88 % for amivantamab-lazertinib versus 85 % for osimertinib. The median duration of response among confirmed responders improved by 8.6 months for amivantamab-lazertinib versus osimertinib. Favorable trends were also seen for overall survival, extracranial progression-free survival, and post-progression outcomes for amivantamab-lazertinib over osimertinib. Adverse events in Asian participants were similar to those in the overall population.
Conclusions: Amivantamab-lazertinib demonstrated superior progression-free survival versus osimertinib in Asian participants, with a tolerable safety profile. These results were consistent with those in the overall population.
Keywords: Amivantamab; Asian patient; EGFR TKI; EGFR-mutated NSCLC.
Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.
Conflict of interest statement
Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Byoung Chul Cho reports consulting or advisory role for AstraZeneca, Boehringer Ingelheim, Roche, Bristol Myers Squibb, Pfizer, Yuhan Corporation, Johnson & Johnson, Takeda, Merck Sharp & Dohme, Ono Pharmaceutical, Eli Lilly, MedPacto, Blueprint Medicines, Cyrus Therapeutics, Guardant Health, Novartis, CJ Bioscience, Abion, BeiGene, CureLogen, Onegene Biotechnology, GI Cell, HK inno.N, Imnewrun Biosciences Inc., RandBio, Hanmi Pharmaceutical, Kanaph Therapeutics, BridgeBio, Oscotec; leadership roles for Interpark Bio, J INTS BIO; patents, royalties, or other intellectual property for Champions Oncology, Crown Bioscience, Imagen; other relationships with DAAN Biotherapeutics; stock ownership or other ownership interests with Theravance, Gencurix, BridgeBio, Kanaph Therapeutics, Cyrus Therapeutics, Interpark Bio, J INTS BIO; research funding from Novartis, Bayer, AstraZeneca, MOGAM Institute for Biomedical Research, Dong-A ST, Champions Oncology, Johnson & Johnson, Yuhan Corporation, Ono Pharmaceutical, Dizal Pharma, Merck Sharp & Dohme, AbbVie, GI Innovation, Eli Lilly, Blueprint Medicines, Interpark Bio, LG Chem, Oscotec, GI Cell, Abion, Boehringer Ingelheim, CJ Bioscience, Cyrus Therapeutics, Genexine, Nuvalent, Oncternal Therapeutics, Regeneron, BridgeBio, ImmuneOncia, Illumina, Kanaph Therapeutics, Therapex, J INTS BIO, Hanmi Pharmaceutical, CHA Bundang Medical Center. Hidetoshi Hayashi reports consulting or advisory role for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo/UCB Japan, Johnson & Johnson; patents, royalties, or other intellectual property for Sysmex; honoraria from Ono Pharmaceutical, Bristol Myers Squibb Japan, Eli Lilly, Boehringer Ingelheim, AstraZeneca Japan, Chugai Pharmaceutical Co., Pfizer, Merck Sharp & Dohme, Novartis, Merck Serono, Amgen, Daiichi Sankyo/UCB Japan, Guardant Health, Takeda, Johnson & Johnson; research funding from Ono Pharmaceutical, Boehringer Ingelheim, AstraZeneca, AbbVie, A C Medical, Astellas, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly Japan, EPS Associates Co., Ltd., GSK, Japan Clinical Research Operations, Kyowa Kirin, Merck Serono, Novartis, Otsuka, Parexel, Pfizer, PPD-SNBL, Quintiles, Taiho Pharma, Takeda, Yakult Honsha, Chugai Pharmaceutical Co., Sysmex, Japan Agency for Medical Research and Development. Jong-Seok Lee reports consulting or advisory role for Yuhan Corporation. Se-Hoon Lee reports honoraria from AstraZeneca/MedImmune, Roche, Merck, Eli Lilly, Amgen; consulting or advisory role for AstraZeneca, Roche, Merck, Pfizer, Eli Lilly, Johnson & Johnson; research funding from Merck. Pongwut Danchaivijitr reports honoraria from Roche, Bristol Myers Squibb, Merck Sharp & Dohme, Johnson & Johnson, Astellas; consulting or advisory role for Roche, Bristol Myers Squibb, Merck Sharp & Dohme, Johnson & Johnson, Astellas, Eisai; speakers bureau for Roche, Bristol Myers Squibb, Merck Sharp & Dohme, Johnson & Johnson, Astellas, Amgen, Eisai; research funding from Merck Sharp & Dohme, Roche, Johnson & Johnson. Adlinda Alip reports honoraria from Astellas, AstraZeneca, Bristol Myers Squibb, Ipsen, Johnson & Johnson, Merck Sharp & Dohme, Pfizer. Soon Hin How reports travel, accommodations, or expenses paid by Merck Sharp & Dohme; honoraria from Roche, Merck Sharp & Dohme, AstraZeneca; research funding from AstraZeneca, Merck Sharp & Dohme, Novartis, Johnson & Johnson. Gee-Chen Chang reports honoraria from Roche, Eli Lilly, AstraZeneca, Novartis, Pfizer, Boehringer Ingelheim, Bristol Myers Squibb, Merck Sharp & Dohme. James Chih-Hsin Yang reports honoraria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Ono Pharmaceutical, Pfizer, Roche, Takeda; consulting or advisory role for AbbVie, Amgen, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Clovis Oncology, Daiichi Sankyo, G1 Therapeutics, GSK, Hansoh Pharma, Incyte, Johnson & Johnson, Eli Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, Ono Pharmaceutical, Pfizer, Takeda, Yuhan Corporation; travel, accommodations, or expenses from Pfizer. Hiroshige Yoshioka reports consulting or advisory role for Delta-Fly Pharma; honoraria from Eli Lilly, Chugai Pharmaceutical Co., Boehringer Ingelheim, Taiho Pharma, AstraZeneca, Bristol Myers Squibb, Ono Pharmaceutical, MSD, Novartis, Daiichi Sankyo, Nippon Kayaku, Delta-Fly Pharma, Pfizer, Otsuka, Takeda, Amgen, Merck; research funding from Merck Sharp & Dohme, Daiichi Sankyo, AstraZeneca, Johnson & Johnson, Novartis, Delta-Fly Pharma, Boehringer Ingelheim. Mehmet Ali Nahit Şendur reports consulting fees from Roche, AstraZeneca, Pfizer, Novartis, Astellas, Bristol Myers Squibb, Merck Sharp & Dohme, Eli Lilly, Gilead, Takeda; payment or honoraria from Roche, AstraZeneca, Pfizer, Novartis, Astellas, Bristol Myers Squibb, Merck Sharp & Dohme, Eli Lilly, Gilead, Takeda. Kumar Prabhash reports research funding from Biocon, Dr. Reddy’s Laboratories, Fresenius Kabi, Alkem Laboratories, Natco Pharma, BDR Pharmaceuticals, Roche. Koichi Azuma reports payment or honoraria from AstraZeneca, Merck Sharp & Dohme, Ono Pharmaceutical, Bristol Myers Squibb, Chugai Pharmaceutical Co. Chien-Chung Lin reports consulting and speaker fees from AstraZeneca, Pfizer, Takeda, Roche, Merck, Boehringer Ingelheim, Johnson & Johnson, Amgen. Shingo Matsumoto reports honoraria from Eli Lilly, Chugai Pharmaceutical Co., Taiho Pharma, AstraZeneca, Daiichi Sankyo, Takeda, Merck Sharp & Dohme; research funding from Johnson & Johnson, Merck Sharp & Dohme, Chugai Pharmaceutical Co. Patrapim Sunpaweravong reports grants or contracts from Mirati Therapeutics, Novartis, Roche, AstraZeneca, Amgen, Merck Sharp & Dohme, Exscientia, Johnson & Johnson, Boehringer Ingelheim; payment or honoraria from Novartis, Roche, AstraZeneca, Taiho Pharma, Amgen, Johnson & Johnson, DKSH, Juniper Biologics, Bristol Myers Squibb, Merck Sharp & Dohme, ZP Therapeutics, Daiichi Sankyo, Eisai; travel, accommodations, or expenses from Pfizer, Bayer, Novartis, Roche, AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, ZP Therapeutics, Taiho Pharma, Eisai, Amgen, Johnson & Johnson, DKSH, Juniper Biologics, Gene Solutions; participation on data safety monitoring or advisory boards for Novartis, Roche, AstraZeneca, Taiho Pharma, Amgen, Johnson & Johnson, DKSH, Juniper Biologics, Bristol Myers Squibb, Merck Sharp & Dohme, ZP Therapeutics, Daiichi Sankyo, Eisai. Yichuan Xia reports employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Melissa Martinez reports employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Joshua M. Bauml reports employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Seema Sethi reports employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Shun Lu reports consulting or advisory role for AstraZeneca, Pfizer, Boehringer Ingelheim, HUTCHMED, Simcere Pharmaceutical, Zai Lab, GenomiCare, Yuhan Corporation, Roche, Menarini, InventisBio Co. Ltd.; speakers bureau for AstraZeneca, Roche, Hansoh Pharma, Jiangsu Hengrui, HUTCHMED, Bristol Myers Squibb, BeiGene, Eli Lilly. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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