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Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC.
Cho, Byoung C; Lu, Shun; Felip, Enriqueta; Spira, Alexander I; Girard, Nicolas; Lee, Jong-Seok; Lee, Se-Hoon; Ostapenko, Yurii; Danchaivijitr, Pongwut; Liu, Baogang; Alip, Adlinda; Korbenfeld, Ernesto; Mourão Dias, Josiane; Besse, Benjamin; Lee, Ki-Hyeong; Xiong, Hailin; How, Soon-Hin; Cheng, Ying; Chang, Gee-Chen; Yoshioka, Hiroshige; Yang, James C-H; Thomas, Michael; Nguyen, Danny; Ou, Sai-Hong I; Mukhedkar, Sanjay; Prabhash, Kumar; D'Arcangelo, Manolo; Alatorre-Alexander, Jorge; Vázquez Limón, Juan C; Alves, Sara; Stroyakovskiy, Daniil; Peregudova, Marina; Sendur, Mehmet A N; Yazici, Ozan; Califano, Raffaele; Gutiérrez Calderón, Vanesa; de Marinis, Filippo; Passaro, Antonio; Kim, Sang-We; Gadgeel, Shirish M; Xie, John; Sun, Tao; Martinez, Melissa; Ennis, Mariah; Fennema, Elizabeth; Daksh, Mahesh; Millington, Dawn; Leconte, Isabelle; Iwasawa, Ryota; Lorenzini, Patricia.
Afiliação
  • Cho BC; From 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-O
  • Lu S; From 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-O
  • Felip E; From 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-O
  • Spira AI; From 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-O
  • Girard N; From 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-O
  • Lee JS; From 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-O
  • Lee SH; From 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-O
  • Ostapenko Y; From 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-O
  • Danchaivijitr P; From 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-O
  • Liu B; From 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-O
  • Alip A; From 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-O
  • Korbenfeld E; From 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-O
  • Mourão Dias J; From 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-O
  • Besse B; From 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-O
  • Lee KH; From 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-O
  • Xiong H; From 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-O
  • How SH; From 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-O
  • Cheng Y; From 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-O
  • Chang GC; From 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-O
  • Yoshioka H; From 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-O
  • Yang JC; From 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-O
  • Thomas M; From 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-O
  • Nguyen D; From 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-O
  • Ou SI; From 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-O
  • Mukhedkar S; From 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-O
  • Prabhash K; From 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-O
  • D'Arcangelo M; From 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-O
  • Alatorre-Alexander J; From 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-O
  • Vázquez Limón JC; From 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-O
  • Alves S; From 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-O
  • Stroyakovskiy D; From 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-O
  • Peregudova M; From 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-O
  • Sendur MAN; From 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-O
  • Yazici O; From 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-O
  • Califano R; From 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-O
  • Gutiérrez Calderón V; From 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-O
  • de Marinis F; From 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-O
  • Passaro A; From 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-O
  • Kim SW; From 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-O
  • Gadgeel SM; From 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-O
  • Xie J; From 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-O
  • Sun T; From 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-O
  • Martinez M; From 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-O
  • Ennis M; From 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-O
  • Fennema E; From 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-O
  • Daksh M; From 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-O
  • Millington D; From 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-O
  • Leconte I; From 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-O
  • Iwasawa R; From 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-O
  • Lorenzini P; From 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-O
N Engl J Med ; 391(16): 1486-1498, 2024 Oct 24.
Article em En | MEDLINE | ID: mdl-38924756
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 221 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.).
Assuntos
Anticorpos Biespecíficos; Protocolos de Quimioterapia Combinada Antineoplásica; Carcinoma Pulmonar de Células não Pequenas; Neoplasias Pulmonares; Morfolinas; Pirazóis; Pirimidinas; Adulto; Idoso; Idoso de 80 Anos ou mais; Feminino; Humanos; Masculino; Pessoa de Meia-Idade; Acrilamidas/uso terapêutico; Compostos de Anilina/uso terapêutico; Antineoplásicos Imunológicos/administração & dosagem; Antineoplásicos Imunológicos/efeitos adversos; Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem; Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos; Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico; Carcinoma Pulmonar de Células não Pequenas/genética; Carcinoma Pulmonar de Células não Pequenas/mortalidade; Carcinoma Pulmonar de Células não Pequenas/patologia; Receptores ErbB/genética; Receptores ErbB/antagonistas & inibidores; Estimativa de Kaplan-Meier; Neoplasias Pulmonares/tratamento farmacológico; Neoplasias Pulmonares/genética; Neoplasias Pulmonares/mortalidade; Neoplasias Pulmonares/patologia; Morfolinas/administração & dosagem; Morfolinas/efeitos adversos; Mutação; Intervalo Livre de Progressão; Inibidores de Proteínas Quinases/administração & dosagem; Inibidores de Proteínas Quinases/efeitos adversos; Quinolinas/uso terapêutico; Pirimidinas/administração & dosagem; Pirimidinas/efeitos adversos; Pirazóis/administração & dosagem; Pirazóis/efeitos adversos; Resultado do Tratamento
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirazóis / Pirimidinas / Protocolos de Quimioterapia Combinada Antineoplásica / Morfolinas / Anticorpos Biespecíficos / Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares Limite: Aged80 Idioma: En Ano de publicação: 2024 Tipo de documento: Article
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirazóis / Pirimidinas / Protocolos de Quimioterapia Combinada Antineoplásica / Morfolinas / Anticorpos Biespecíficos / Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares Limite: Aged80 Idioma: En Ano de publicação: 2024 Tipo de documento: Article