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Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC
Byoung C Cho1, Shun Lu1, Enriqueta Felip1
1From the Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine (B.C.C.), Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-H.L.), and the Lung Cancer Center, Asan Medical Center Cancer Institute (S.-W.K.), Seoul, the Department of Hematology-Oncology, Seoul National University Bundang Hospital, Seongnam (J.-S.L.), and the Medical Department, Chungbuk National University Hospital, Cheongju (K.-H.L.) - all in South Korea; the Department of Medical Oncology, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai (S.L.), Harbin Medical University Cancer Hospital, Harbin (B.L.), the Department of Medical Oncology, Huizhou Municipal Central Hospital of Guangdong Province, Huizhou (H.X.), and Jilin Cancer Hospital, Changchun (Y.C.) - all in China; the Medical Oncology Service, Vall d'Hebron Barcelona Hospital Campus-Vall d'Hebron University Hospital, Barcelona (E. Felip), and the Medical Oncology Department, Hospital Regional Universitario de Málaga y Virgen de la Victoria, Institute of Biomedical Research of Malaga, Malaga (V.G.C.) - both in Spain; Virginia Cancer Specialists, Fairfax (A.I.S.); Institut Curie, Institut du Thorax Curie-Montsouris, Paris (N.G.), and Paris-Saclay University, Université de Versailles Saint-Quentin-en-Yvelines, Versailles (N.G.), and Paris-Saclay University and Institut Gustave Roussy, Villejuif (B.B.) - all in France; the National Cancer Institute, Kyiv, Ukraine (Y.O.); the Division of Medical Oncology, Department of Medicine, Siriraj Hospital Faculty of Medicine, Mahidol University Bangkok Noi Campus, Bangkok, Thailand (P.D.); the Clinical Oncology Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur (A.A.), and the Department of Internal Medicine, Division of Respiratory Medicine, International Islamic University Malaysia Medical Specialist Center, Pahang (S.-H.H.) - both in Malaysia; British Hospital of Buenos Aires, Central British Hospital, Buenos Aires (E.K.); the Department of Medical Oncology, Barretos Cancer Hospital, São Paulo (J.M.D.); the School of Medicine and Institute of Medicine, Chung Shan Medical University, and the Division of Pulmonary Medicine, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung (G.-C.C.), and the Department of Medical Oncology, National Taiwan University Cancer Center, Taipei (J.C.-H.Y.) - both in Taiwan; the Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata (H.Y.), and the Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka (H.H.) - both in Japan; the Department of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital, and the National Center for Tumor Diseases Heidelberg, German Center for Lung Research, Heidelberg, Germany (M.T.); City of Hope National Medical Center, Duarte (D.N.), Chao Family Comprehensive Cancer Center, University of California, Irvine, School of Medicine, Orange (S.-H.I.O.), and Janssen Research and Development, San Diego (E. Fennema, D.M., S.M.S.) - all in California; St. John of God Murdoch Hospital, Murdoch, WA, Australia (S.M.); the Department of Medical Oncology, Division of Adult Solid Tumor, Tata Memorial Center and Homi Bhabha National Institute, Mumbai, India (K.P.); the Local Health Unit Authority of Romagna, Ravenna Hospital and Department of Onco-Hematology, Santa Maria delle Croci Hospital of Ravenna, Ravenna (M. D'Arcangelo), and the Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan (F.M., A.P.) - both in Italy; Health Pharma Professional Research, Mexico City (J.A.-A.), Oncología Médica, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde," Guadalajara, and Universidad de Guadalajara, Guadalajara (J.C.V.L.) - all in Mexico; Instituto Português de Oncologia do Porto, Porto, Portugal (S.A.); Moscow City Oncology Hospital No. 62 (D.S.) and the Medical Center in Kolomenskoe (M.P.) - both in Moscow; the Department of Medical Oncology, Ankara Bilkent City Hospital and Ankara Yıldırım Beyazıt University (M.A.N.Ş.), and the Department of Medical Oncology, Gazi University Faculty of Medicine (O.Y.) - both in Ankara, Turkey; the Department of Medical Oncology, Christie NHS Foundation Trust and Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom (R.C.); the Division of Hematology-Oncology, Henry Ford Cancer Institute, Henry Ford Health, Detroit (S.M.G.); Janssen Research and Development, Raritan, NJ (J.X., T.S., M.M., M. Daksh, M.B.); Janssen Research and Development, Spring House, PA (M.E., R.I., P.L., S. Shah, J.M.B., S. Sethi, R.E.K.); and Johnson and Johnson Clinical Innovation, Campus Basel, Allschwil, Switzerland (I.L.).
Amivantamab plus lazertinib significantly improved progression-free survival in patients with EGFR-mutated advanced non-small-cell lung cancer. This combination therapy demonstrated superior efficacy compared to osimertinib as a first-line treatment option.
Area of Science:
- Oncology
- Pharmacology
Background:
- Amivantamab plus lazertinib demonstrates efficacy in EGFR-mutated advanced non-small-cell lung cancer (NSCLC).
- Previous treatments showed limitations in previously untreated or osimertinib-pretreated patients.
Purpose of the Study:
- To evaluate the efficacy of amivantamab plus lazertinib versus osimertinib in first-line treatment for EGFR-mutated advanced NSCLC.
- To compare progression-free survival (PFS) as the primary endpoint.
Main Methods:
- Phase 3, international, randomized trial comparing amivantamab-lazertinib, osimertinib, and lazertinib.
- Patients with EGFR mutations (exon 19 deletion or L858R) were randomized in a 2:2:1 ratio.
- Primary endpoint: PFS assessed by blinded independent central review.
Main Results:
- Median PFS was significantly longer with amivantamab-lazertinib (23.7 months) versus osimertinib (16.6 months).
- Objective response rates were high for both arms (86% vs. 85%), with longer response duration for amivantamab-lazertinib.
- Treatment-related adverse events led to discontinuation in 10% of amivantamab-lazertinib patients and 3% of osimertinib patients.
Conclusions:
- Amivantamab plus lazertinib demonstrated superior efficacy compared to osimertinib as first-line treatment for EGFR-mutated advanced NSCLC.
- The combination therapy offers a promising new option for this patient population.
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