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Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC

Yang, J. C.
; 
Lu, S.
; 
Hayashi, H.
; 
Felip, E.
; 
Spira, A. I.
; 
Girard, N.
; 
Kim, Y. J.
; 
Lee, S. H.
; 
Ostapenko, Y.
; 
Danchaivijitr, P.
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Abstract
BACKGROUND: Previous results from this phase 3 trial showed that progression-free survival among participants with previously untreated EGFR (epidermal growth factor receptor)-mutated advanced non-small-cell lung cancer (NSCLC) was significantly improved with amivantamab-lazertinib as compared with osimertinib. Results of the protocol-specified final overall survival analysis in this trial have not been reported. METHODS: We randomly assigned, in a 2:2:1 ratio, participants with previously untreated EGFR-mutated (exon 19 deletion or L858R substitution), locally advanced or metastatic NSCLC to receive amivantamab-lazertinib, osimertinib, or lazertinib. Overall survival (assessed in an analysis of the time from randomization to death from any cause) in the amivantamab-lazertinib group as compared with the osimertinib group was a key secondary end point. Additional end points included safety. RESULTS: A total of 429 participants each were assigned to receive amivantamab-lazertinib or osimertinib. Over a median follow-up of 37.8 months, amivantamab-lazertinib led to significantly longer overall survival than osimertinib (hazard ratio for death, 0.75; 95% confidence interval, 0.61 to 0.92; P = 0.005); 3-year overall survival was 60% and 51%, respectively. At the clinical cutoff date, 38% of participants in the amivantamab-lazertinib group and 28% in the osimertinib group were still receiving the assigned treatment. Adverse events of grade 3 or higher were more common with amivantamab-lazertinib (in 80% of participants) than with osimertinib (in 52%), particularly skin-related events, venous thromboembolism, and infusion-related events; these findings were consistent with the established safety profile of each treatment. No new safety signals were observed with additional follow-up. CONCLUSIONS: Amivantamab-lazertinib led to significantly longer overall survival among participants with previously untreated EGFR-mutated advanced NSCLC than osimertinib but was associated with an increased risk of adverse events of grade 3 or higher. (Funded by Janssen Research and Development; MARIPOSA ClinicalTrials.gov number, NCT04487080.).
Authors
Yang, J. C.
Lu, S.
Hayashi, H.
Felip, E.
Spira, A. I.
Girard, N.
Kim, Y. J.
Lee, S. H.
Ostapenko, Y.
Danchaivijitr, P.
Liu, B.
Alip, A.
Korbenfeld, E.
Mourão Dias, J.
Besse, B.
Passaro, A.
Lee, K. H.
Xiong, H.
How, S. H.
Cheng, Y.
Chang, G. C.
Yoshioka, H.
Thomas, M.
Nguyen, D.
Ou, S. I.
Mukhedkar, S.
Prabhash, K.
D'Arcangelo, M.
Alatorre-Alexander, J.
Vázquez Limón, J. C.
Alves, S.
Stroyakovskiy, D.
Peregudova, M.
Şendur, M. A. N.
Yazici, O.
Califano, R.
Gutiérrez Calderón, V.
de Marinis, F.
Kim, S. W.
Gadgeel, S. M.
Owen, S.
Xie, J.
Sun, T.
Mehta, J.
Venkatasubramanian, R.
Ennis, M.
Fennema, E.
Daksh, M.
Roshak, A.
Man, J.
Knoblauch, R. E.
Bauml, J. M.
Baig, M.
Shah, S.
Sethi, S.
Cho, B. C.
Affiliation
National Taiwan University Cancer Center, National Taiwan University Hospital, Taipei, Taiwan. Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan. Medical Oncology Service, Vall d'Hebron Institute of Oncology, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona. Virginia Cancer Specialists, Fairfax. Institut Curie, Paris. Paris-Saclay University, Université de Versailles Saint-Quentin-en-Yvelines, Versailles, France. Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. National Cancer Institute, Kyiv, Ukraine. Division of Medical Oncology, Department of Medicine, Siriraj Hospital Faculty of Medicine, Mahidol University Bangkok Noi Campus, Bangkok, Thailand. Harbin Medical University Cancer Hospital, Harbin, China. Clinical Oncology Department, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. British Hospital of Buenos Aires, Central British Hospital, Buenos Aires. Department of Medical Oncology, Barretos Cancer Hospital, São Paulo. Paris-Saclay University, Gustave Roussy, Villejuif, France. Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan. Medical Department, Chungbuk National University Hospital, Cheongju, South Korea. Department of Medical Oncology, Huizhou Municipal Central Hospital of Guangdong Province, Huizhou, China. Department of Internal Medicine, Division of Respiratory Medicine, International Islamic University Malaysia Medical Specialist Center, Pahang, Malaysia. Jilin Cancer Hospital, Changchun, China. School of Medicine and Institute of Medicine, Chung Shan Medical University and Division of Pulmonary Medicine, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan. Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan. Department of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany. National Center for Tumor Diseases Heidelberg, a partnership between the German Cancer Research Center and Heidelberg University Hospital, Heidelberg, Germany. Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany. City of Hope National Medical Center, Duarte, CA. University of California, Irvine School of Medicine, Orange. St. John of God Murdoch Hospital, Murdoch, WA, Australia. Department of Medical Oncology, Division of Adult Solid Tumor Oncology, Tata Memorial Hospital, Mumbai, India. Local Health Unit Authority of Romagna, Ravenna Hospital and Department of Onco-Hematology, Santa Maria delle Croci Hospital of Ravenna, Emilia-Romagna, Italy. Health Pharma Professional Research, Mexico City. Oncología Médica, Antiguo Hospital Civil de Guadalajara 'Fray Antonio Alcalde' and Universidad de Guadalajara, Guadalajara, Mexico. Instituto Português de Oncologia do Porto Francisco Gentil, Porto, Portugal. Moscow City Oncology Hospital No. 62, Moscow. Medical Center in Kolomenskoe, Moscow. Department of Medical Oncology, Ankara Bilkent City Hospital and Ankara Yıldırım Beyazıt University, Ankara, Turkey. Department of Medical Oncology, Gazi University Faculty of Medicine, Ankara, Turkey. Department of Medical Oncology, Christie NHS Foundation Trust and Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom. Medical Oncology Department, Hospital Regional Universitario de Málaga, Málaga, Spain. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Division of Hematology-Oncology, Henry Ford Cancer Institute, Henry Ford Health, Detroit. Department of Medical Oncology, McGill University Health Centre, Montreal. Johnson & Johnson, Raritan, NJ. Johnson & Johnson, Spring House, PA. Johnson & Johnson, Titusville, NJ. Johnson & Johnson, San Diego, CA. Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Description
Date
2025
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Article
Citation
Yang JC, Lu S, Hayashi H, Felip E, Spira AI, Girard N, et al. Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC. The New England journal of medicine. 2025 Sep 7. PubMed PMID: 40923797. Epub 2025/09/09. eng.
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https://christie.openrepository.com/handle/10541/627951
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