Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC
6
Issued Date
2025-10-30
Resource Type
eISSN
15334406
Scopus ID
2-s2.0-105020620968
Pubmed ID
40923797
Journal Title
New England Journal of Medicine
Volume
393
Issue
17
Start Page
1681
End Page
1693
Rights Holder(s)
SCOPUS
Bibliographic Citation
New England Journal of Medicine Vol.393 No.17 (2025) , 1681-1693
Suggested Citation
Yang J.C.H., 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.H.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. Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC. New England Journal of Medicine Vol.393 No.17 (2025) , 1681-1693. 1693. doi:10.1056/NEJMoa2503001 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/112975
Title
Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC
Author(s)
Yang J.C.H.
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.H.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.
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.H.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.
Author's Affiliation
Universitat Autònoma de Barcelona
Universiti Malaya
German Cancer Research Center
National Taiwan University Hospital
UCI School of Medicine
Asan Medical Center
Samsung Medical Center, Sungkyunkwan university
Université de Versailles Saint-Quentin-en-Yvelines
Institut de Cancerologie Gustave Roussy
Harbin Medical University
Institut Curie
Faculty of Biology, Medicine and Health
City of Hope National Med Center
International Islamic University Malaysia
Seoul National University Bundang Hospital
Centre Universitaire de Santé McGill
Istituto Europeo di Oncologia
Chung Shan Medical University Hospital
Kindai University School of Medicine
Tata Memorial Hospital
Ankara Yildirim Beyazit University
Hospital Regional Universitario Carlos Haya
Gazi University, Faculty of Medicine
Faculty of Medicine Siriraj Hospital, Mahidol University
Johnson & Johnson
Shanghai Chest Hospital
Johnson & Johnson Pharmaceutical Research & Development, Raritan
Instituto Português de Oncologia do Porto FG
Chungbuk National University Hospital
Hospital Civil de Guadalajara
Yonsei Cancer Hospital
Thoraxklinik am Universitatsklinikum Heidelberg
Ospedale S. Maria delle Croci
Hospital de Câncer de Barretos
Hospital Britanico de Buenos Aires
St John of God Health Care
Kansai Medical University Hospital
National Cancer Institute of Ukraine
German Center for Lung Research
Virginia Cancer Specialists
Moscow City Oncology Hospital No. 62
Henry Ford Health
Jilin Cancer Hospital
Huizhou Municipal Central Hospital of Guangdong Province
Health Pharma Professional Research
Medical Center in Kolomenskoe
Universiti Malaya
German Cancer Research Center
National Taiwan University Hospital
UCI School of Medicine
Asan Medical Center
Samsung Medical Center, Sungkyunkwan university
Université de Versailles Saint-Quentin-en-Yvelines
Institut de Cancerologie Gustave Roussy
Harbin Medical University
Institut Curie
Faculty of Biology, Medicine and Health
City of Hope National Med Center
International Islamic University Malaysia
Seoul National University Bundang Hospital
Centre Universitaire de Santé McGill
Istituto Europeo di Oncologia
Chung Shan Medical University Hospital
Kindai University School of Medicine
Tata Memorial Hospital
Ankara Yildirim Beyazit University
Hospital Regional Universitario Carlos Haya
Gazi University, Faculty of Medicine
Faculty of Medicine Siriraj Hospital, Mahidol University
Johnson & Johnson
Shanghai Chest Hospital
Johnson & Johnson Pharmaceutical Research & Development, Raritan
Instituto Português de Oncologia do Porto FG
Chungbuk National University Hospital
Hospital Civil de Guadalajara
Yonsei Cancer Hospital
Thoraxklinik am Universitatsklinikum Heidelberg
Ospedale S. Maria delle Croci
Hospital de Câncer de Barretos
Hospital Britanico de Buenos Aires
St John of God Health Care
Kansai Medical University Hospital
National Cancer Institute of Ukraine
German Center for Lung Research
Virginia Cancer Specialists
Moscow City Oncology Hospital No. 62
Henry Ford Health
Jilin Cancer Hospital
Huizhou Municipal Central Hospital of Guangdong Province
Health Pharma Professional Research
Medical Center in Kolomenskoe
Corresponding Author(s)
Other Contributor(s)
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.).