Amivantamab plus Lazertinib in Previously Untreated EGFR -Mutated Advanced NSCLC.
Issued Date
2024-10-24
Resource Type
ISSN
00284793
eISSN
15334406
Scopus ID
2-s2.0-85199638052
Pubmed ID
38924756
Journal Title
New England Journal of Medicine
Volume
391
Issue
16
Start Page
1486
End Page
1498
Rights Holder(s)
SCOPUS
Bibliographic Citation
New England Journal of Medicine Vol.391 No.16 (2024) , 1486-1498
Suggested Citation
Cho B.C., Lu S., Felip E., Spira A.I., Girard N., Lee J.S., Lee S.H., Ostapenko Y., Danchaivijitr P., Liu B., Alip A., Korbenfeld E., Mourão Dias J., Besse B., Lee K.H., Xiong H., How S.H., Cheng Y., Chang G.C., Yoshioka H., Yang J.C.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., Passaro A., Kim S.W., Gadgeel S.M., Xie J., Sun T., Martinez M., Ennis M., Fennema E., Daksh M., Millington D., Leconte I., Iwasawa R., Lorenzini P., Baig M., Shah S., Bauml J.M., Shreeve S.M., Sethi S., Knoblauch R.E., Hayashi H. Amivantamab plus Lazertinib in Previously Untreated EGFR -Mutated Advanced NSCLC.. New England Journal of Medicine Vol.391 No.16 (2024) , 1486-1498. 1498. doi:10.1056/NEJMoa2403614 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/101976
Title
Amivantamab plus Lazertinib in Previously Untreated EGFR -Mutated Advanced NSCLC.
Author(s)
Cho B.C.
Lu S.
Felip E.
Spira A.I.
Girard N.
Lee J.S.
Lee S.H.
Ostapenko Y.
Danchaivijitr P.
Liu B.
Alip A.
Korbenfeld E.
Mourão Dias J.
Besse B.
Lee K.H.
Xiong H.
How S.H.
Cheng Y.
Chang G.C.
Yoshioka H.
Yang J.C.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.
Passaro A.
Kim S.W.
Gadgeel S.M.
Xie J.
Sun T.
Martinez M.
Ennis M.
Fennema E.
Daksh M.
Millington D.
Leconte I.
Iwasawa R.
Lorenzini P.
Baig M.
Shah S.
Bauml J.M.
Shreeve S.M.
Sethi S.
Knoblauch R.E.
Hayashi H.
Lu S.
Felip E.
Spira A.I.
Girard N.
Lee J.S.
Lee S.H.
Ostapenko Y.
Danchaivijitr P.
Liu B.
Alip A.
Korbenfeld E.
Mourão Dias J.
Besse B.
Lee K.H.
Xiong H.
How S.H.
Cheng Y.
Chang G.C.
Yoshioka H.
Yang J.C.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.
Passaro A.
Kim S.W.
Gadgeel S.M.
Xie J.
Sun T.
Martinez M.
Ennis M.
Fennema E.
Daksh M.
Millington D.
Leconte I.
Iwasawa R.
Lorenzini P.
Baig M.
Shah S.
Bauml J.M.
Shreeve S.M.
Sethi S.
Knoblauch R.E.
Hayashi H.
Author's Affiliation
Faculty of Biology, Medicine and Health
Kansai Medical University Hospital
Yonsei Cancer Hospital
National Cancer Institute of Ukraine
Ankara Yildirim Beyazit University
Université Paris-Saclay
Chungbuk National University Hospital
Seoul National University Bundang Hospital
Hospital de Câncer de Barretos
Homi Bhabha National Institute
Shanghai Chest Hospital
Chung Shan Medical University Hospital
National Taiwan University Hospital
Janssen Research & Development
Asan Medical Center
Kindai University School of Medicine
Institut Curie
Istituto Europeo di Oncologia
Université de Versailles Saint-Quentin-en-Yvelines
Universiti Malaya
Chung Shan Medical University
St John of God Health Care
Harbin Medical University
Gazi University, Faculty of Medicine
Samsung Medical Center, Sungkyunkwan university
Ospedale S. Maria delle Croci
International Islamic University Malaysia
Hospital Regional Universitario Carlos Haya
Hospital Universitari Vall d'Hebron
Faculty of Medicine Siriraj Hospital, Mahidol University
Johnson & Johnson
Universidad de Guadalajara
UCI School of Medicine
City of Hope National Med Center
Instituto Português de Oncologia do Porto FG
Hospital Britanico de Buenos Aires
Thoraxklinik am Universitatsklinikum Heidelberg
Medical Center in Kolomenskoe
Health Pharma Professional Research
Moscow City Oncology Hospital No. 62
Huizhou Municipal Central Hospital of Guangdong Province
Henry Ford Health
Jilin Cancer Hospital
Virginia Cancer Specialists
Kansai Medical University Hospital
Yonsei Cancer Hospital
National Cancer Institute of Ukraine
Ankara Yildirim Beyazit University
Université Paris-Saclay
Chungbuk National University Hospital
Seoul National University Bundang Hospital
Hospital de Câncer de Barretos
Homi Bhabha National Institute
Shanghai Chest Hospital
Chung Shan Medical University Hospital
National Taiwan University Hospital
Janssen Research & Development
Asan Medical Center
Kindai University School of Medicine
Institut Curie
Istituto Europeo di Oncologia
Université de Versailles Saint-Quentin-en-Yvelines
Universiti Malaya
Chung Shan Medical University
St John of God Health Care
Harbin Medical University
Gazi University, Faculty of Medicine
Samsung Medical Center, Sungkyunkwan university
Ospedale S. Maria delle Croci
International Islamic University Malaysia
Hospital Regional Universitario Carlos Haya
Hospital Universitari Vall d'Hebron
Faculty of Medicine Siriraj Hospital, Mahidol University
Johnson & Johnson
Universidad de Guadalajara
UCI School of Medicine
City of Hope National Med Center
Instituto Português de Oncologia do Porto FG
Hospital Britanico de Buenos Aires
Thoraxklinik am Universitatsklinikum Heidelberg
Medical Center in Kolomenskoe
Health Pharma Professional Research
Moscow City Oncology Hospital No. 62
Huizhou Municipal Central Hospital of Guangdong Province
Henry Ford Health
Jilin Cancer Hospital
Virginia Cancer Specialists
Corresponding Author(s)
Other Contributor(s)
Abstract
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.)