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Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC

BACKGROUND: Amivantamab plus lazertinib (amivantamab-lazertinib) has shown clinically meaningful and durable antitumor activity in patients with previously untreated or osimertinib-pretreated EGFR (epidermal growth factor receptor)-mutated advanced non-small-cell lung cancer (NSCLC). - METHODS: In a...

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Main Authors: Cho, Byoung C. (Author) , Lu, Shun (Author) , Felip, Enriqueta (Author) , Spira, Alexander I. (Author) , Girard, Nicolas (Author) , Lee, Jong-Seok (Author) , Lee, Se-Hoon (Author) , Ostapenko, Yurii (Author) , Danchaivijitr, Pongwut (Author) , Liu, Baogang (Author) , Alip, Adlinda (Author) , Korbenfeld, Ernesto (Author) , Mourão Dias, Josiane (Author) , Besse, Benjamin (Author) , Lee, Ki-Hyeong (Author) , Xiong, Hailin (Author) , How, Soon-Hin (Author) , Cheng, Ying (Author) , Chang, Gee-Chen (Author) , Yoshioka, Hiroshige (Author) , Yang, James C.-H. (Author) , Thomas, Michael (Author) , Nguyen, Danny (Author) , Ou, Sai-Hong I. (Author) , Mukhedkar, Sanjay (Author) , Prabhash, Kumar (Author) , D'Arcangelo, Manolo (Author) , Alatorre-Alexander, Jorge (Author) , Vázquez Limón, Juan C. (Author) , Alves, Sara (Author) , Stroyakovskiy, Daniil (Author) , Peregudova, Marina (Author) , Şendur, Mehmet A. N. (Author) , Yazici, Ozan (Author) , Califano, Raffaele (Author) , Gutiérrez Calderón, Vanesa (Author) , de Marinis, Filippo (Author) , Passaro, Antonio (Author) , Kim, Sang-We (Author) , Gadgeel, Shirish M. (Author) , Xie, John (Author) , Sun, Tao (Author) , Martinez, Melissa (Author) , Ennis, Mariah (Author) , Fennema, Elizabeth (Author) , Daksh, Mahesh (Author) , Millington, Dawn (Author) , Leconte, Isabelle (Author) , Iwasawa, Ryota (Author) , Lorenzini, Patricia (Author) , Baig, Mahadi (Author) , Shah, Sujay (Author) , Bauml, Joshua M. (Author) , Shreeve, S. Martin (Author) , Sethi, Seema (Author) , Knoblauch, Roland E. (Author) , Hayashi, Hidetoshi (Author)
Format: Article (Journal)
Language:English
Published: June 26, 2024
In: The New England journal of medicine
Year: 2024, Volume: 391, Issue: 16, Pages: 1486-1498
ISSN:1533-4406
DOI:10.1056/NEJMoa2403614
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1056/NEJMoa2403614
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Author Notes:B.C. Cho, S. Lu, E. Felip, A.I. Spira, N.Girard, J.-S. Lee, S.-H. Lee, Y. Ostapenko, P. Danchaivijitr, B. Liu, A. Alip, E. Korbenfeld, J. Mourão Dias, B. Besse, K.-H. Lee, H. Xiong, S.-H. How, Y. Cheng, G.-C. Chang, H. Yoshioka, J.C.-H. Yang, M. Thomas, D. Nguyen, S.-H.I. Ou, S. Mukhedkar, K. Prabhash, M. D'Arcangelo, J.Alatorre-Alexander, J.C. Vázquez Limón, S. Alves, D. Stroyakovskiy, M. Peregudova, M.A.N. Şendur, O. Yazici, R. Califano, V. Gutiérrez Calderón, F. de Marinis, A. Passaro, S.-W. Kim, S.M. Gadgeel, J. Xie, T. Sun, M. Martinez, M. Ennis, E. Fennema, M. Daksh, D. Millington, I. Leconte, R. Iwasawa, P. Lorenzini, M. Baig, S. Shah, J.M. Bauml, S.M. Shreeve, S. Sethi, R.E. Knoblauch, H. Hayashi, for the MARIPOSA Investigators

MARC

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520 |a BACKGROUND: Amivantamab plus lazertinib (amivantamab-lazertinib) has shown clinically meaningful and durable antitumor activity in patients with previously untreated or osimertinib-pretreated EGFR (epidermal growth factor receptor)-mutated advanced non-small-cell lung cancer (NSCLC). - 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.). 
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