Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC.
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Cho Byoung C, Lu Shun, Felip Enriqueta, Spira Alexander I, Girard Nicolas, Lee Jong-Seok, Lee Se-Hoon, Ostapenko Yurii, Danchaivijitr Pongwut, Liu Baogang, Alip Adlinda, Korbenfeld Ernesto, Mourão Dias Josiane, Besse Benjamin, Lee Ki-Hyeong, Xiong Hailin, How Soon-Hin, Cheng Ying, Chang Gee-Chen, Yoshioka Hiroshige, Yang James C-H, Thomas Michael, Nguyen Danny, Ou Sai-Hong I, Mukhedkar Sanjay, Prabhash Kumar, D'Arcangelo Manolo, Alatorre-Alexander Jorge, Vázquez Limón Juan C, Alves Sara, Stroyakovskiy Daniil, Peregudova Marina, Şendur Mehmet A N, Yazici Ozan, Califano Raffaele, Gutiérrez Calderón Vanesa, de Marinis Filippo, Passaro Antonio, Kim Sang-We, Gadgeel Shirish M, Xie John, Sun Tao, Martinez Melissa, Ennis Mariah, Fennema Elizabeth, Daksh Mahesh, Millington Dawn, Leconte Isabelle, Iwasawa Ryota, Lorenzini Patricia, Baig Mahadi, Shah Sujay, Bauml Joshua M, Shreeve S Martin, Sethi Seema, Knoblauch Roland E, Hayashi Hidetoshi, MARIPOSA Investigators
Аннотация
METHODS: In a phase 3, international, randomized trial, we assigned, in a 2:2:1 ratio, patients with previously untreated EGFR-mutated (exon 19 deletion or L858R), locally advanced or metastatic NSCLC to receive amivantamab-lazertinib (in an open-label fashion), osimertinib (in a blinded fashion), or lazertinib (in a blinded fashion, to assess the contribution of treatment components). The primary end point was progression-free survival in the amivantamab-lazertinib group as compared with the osimertinib group, as assessed by blinded independent central review.
RESULTS: Overall, 1074 patients underwent randomization (429 to amivantamab-lazertinib, 429 to osimertinib, and 216 to lazertinib). The median progression-free survival was significantly longer in the amivantamab-lazertinib group than in the osimertinib group (23.7 vs. 16.6 months; hazard ratio for disease progression or death, 0.70; 95% confidence interval [CI], 0.58 to 0.85; P<0.001). An objective response was observed in 86% of the patients (95% CI, 83 to 89) in the amivantamab-lazertinib group and in 85% of those (95% CI, 81 to 88) in the osimertinib group; among patients with a confirmed response (336 in the amivantamab-lazertinib group and 314 in the osimertinib group), the median response duration was 25.8 months (95% CI, 20.1 to could not be estimated) and 16.8 months (95% CI, 14.8 to 18.5), respectively. In a planned interim overall survival analysis of amivantamab-lazertinib as compared with osimertinib, the hazard ratio for death was 0.80 (95% CI, 0.61 to 1.05). Predominant adverse events were EGFR-related toxic effects. The incidence of discontinuation of all agents due to treatment-related adverse events was 10% with amivantamab-lazertinib and 3% with osimertinib.
CONCLUSIONS: Amivantamab-lazertinib showed superior efficacy to osimertinib as first-line treatment in EGFR-mutated advanced NSCLC. (Funded by Janssen Research and Development; MARIPOSA ClinicalTrials.gov number, NCT04487080.).