Lung cancer (Amsterdam, Netherlands) · 2025
Amivantamab plus lazertinib versus osimertinib as first-line treatment in EGFR-mutated advanced non-small cell lung cancer: MARIPOSA Asian subset.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Cho Byoung Chul, Hayashi Hidetoshi, Lee Jong-Seok, Lee Se-Hoon, Danchaivijitr Pongwut, Cheng Ying, Liu Baogang, Alip Adlinda, Xiong Hailin, How Soon Hin, Chang Gee-Chen, Yang James Chih-Hsin, Yoshioka Hiroshige, Nahit Şendur Mehmet Ali, Prabhash Kumar, Azuma Koichi, Lee Yun-Gyoo, Lin Chien-Chung, Matsumoto Shingo, Sunpaweravong Patrapim, Xia Yichuan, Martinez Melissa, Bauml Joshua M, Sethi Seema, Lu Shun
Аннотация
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.
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.