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Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: Primary results from the phase 3 MARIPOSA-2 study

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资源类型：
Pubmed体系：
作者：
Passaro A[1,*1] ; Wang Jie[2] ; Wang Y[3] ; Lee S-H[4] ; Melosky B[5] ; Shih J-Y[6] ; Wang Jialei[7] ; Azuma K[8] ; Juan-Vidal O[9] ; Cobo M[10] ; Felip E[11] ; Girard N[12] ; Cortot A B[13] ; Califano R[14] ; Cappuzzo F[15] ; Owen S[16] ; Popat S[17] ; Tan J-L[18] ; Salinas J[19] ; Tomasini P[20] ; Gentzler R D[21] ; William W N[22] ; Reckamp K L[23] ; Takahashi T[24] ; Ganguly S[25] ; Kowalski D M[26] ; Bearz A[27] ; MacKean M[28] ; Barala P[29] ; Bourla A B[30] ; Girvin A[29] ; Greger J[29] ; Millington D[31] ; Withelder M[29] ; Xie J[30] ; Sun T[30] ; Shah S[29] ; Diorio B[30] ; Knoblauch R E[29] ; Bauml J M[29] ; Campelo R G[32] ; Cho B C[33] ;
机构： [1]Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan, Italy [2]Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China [3]Department of Thoracic Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University, Chengdu, China [4]Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea [5]British Columbia Cancer Agency, Vancouver, Canada [6]Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan [7]Fudan University Shanghai Cancer Center, Shanghai, China [8]Kurume University School of Medicine, Kurume, Japan [9]Hospital Universitari i Politécnic La Fe, Valencia, Spain [10]Medical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, IBIMA, Málaga, Spain [11]Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain [12]Institut Curie, Institut du Thorax Curie-Montsouris, Paris, France [P]aris Saclay University, UVSQ, Versailles, France [13]University of Lille, CHU Lille, CNRS, Inserm, Institut Pasteur de Lille, UMR9020 – UMR1277 -Canther – Cancer Heterogeneity, Plasticity and Resistance to Therapies, F-59000, Lille, France [14]Department of Medical Oncology, Christie NHS Foundation Trust and Division of Cancer Sciences, The University of Manchester, Manchester, United Kingdom [15]IRCCS Regina Elena National Cancer Institute, Rome, Italy [16]Department of Medical Oncology, McGill University Health Centre, Montreal, Quebec, Canada [17]Royal Marsden Hospital NHS Foundation Trust and The Institute of Cancer Research, London, UK [18]Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia [19]Centro de Especialidades Medicas Ambulatorias e Investigación Clínica, Córdoba, Argentina [20]Multidisciplinary Oncology and Therapeutic Innovations Department, Assistance publique—Hôpitaux de Marseille, Aix-Marseille University, Marseille, France [21]Hematology/Oncology, University of Virginia Cancer Center, Charlottesville, VA, USA [22]Centro Oncológico BP, Beneficência Portuguesa de São Paulo, and Grupo Oncoclínicas, São Paulo, Brazil [23]Cedars-Sinai Medical Center, Los Angeles, CA, USA [24]Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan25Tata Medical Center, Kolkata, India [26]Department of Lung Cancer and Thoracic Tumours, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland [27]Medical Oncology, Centro di Riferimento Oncologico - CRO, Aviano, Italy [28]Edinburgh Cancer Centre, Western, Edinburgh, UK [29]Janssen Research & Development, Spring House, PA, USA [30]Janssen Research & Development, Raritan, NJ, USA [31]Janssen Research & Development, San Diego, CA, USA [32]University Hospital A Coruña, A Coruña, Spain [33]Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea
出处：
DOI： 10.1016/j.annonc.2023.10.117
ISSN：

关键词： amivantamab lazertinib EGFR-mutated NSCLC post-osimertinib

摘要：
Amivantamab plus carboplatin-pemetrexed (chemotherapy) with and without lazertinib demonstrated antitumor activity in patients with refractory EGFR-mutated advanced non-small cell lung cancer (NSCLC) in phase 1 studies. These combinations were evaluated in a global phase 3 trial.A total of 657 patients with EGFR-mutated (exon 19 deletions or L858R) locally advanced or metastatic NSCLC after disease progression on osimertinib were randomized 2:2:1 to receive amivantamab-lazertinib-chemotherapy, chemotherapy, or amivantamab-chemotherapy. The dual primary endpoints were progression-free survival of amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy versus chemotherapy. During the study, hematologic toxicities observed in the amivantamab-lazertinib-chemotherapy arm necessitated a regimen change to start lazertinib after carboplatin completion.All baseline characteristics were well balanced across the 3 arms, including by history of brain metastases and prior brain radiation. Progression-free survival was significantly longer for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy versus chemotherapy (hazard ratio for disease progression or death [HR], 0.48 and 0.44, respectively; P<0.001 for both; median of 6.3 and 8.3 versus 4.2 months, respectively). Consistent PFS results were seen by investigator assessment (HR, 0.41 and 0.38 for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy, respectively; P<0.001 for both; median of 8.2 and 8.3 versus 4.2 months, respectively). Objective response rate was significantly higher for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy versus chemotherapy (64% and 63% versus 36%, respectively; P<0.001 for both). Median intracranial progression-free survival was 12.5 and 12.8 versus 8.3 months for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy versus chemotherapy (hazard ratio for intracranial disease progression or death, 0.55 and 0.58, respectively). Predominant adverse events in the amivantamab-containing regimens were hematologic, EGFR, and MET-related toxicities. Amivantamab-chemotherapy had lower rates of hematologic adverse events than amivantamab-lazertinib-chemotherapy.Amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy improved progression-free survival and intracranial progression-free survival versus chemotherapy in a population with limited options after disease progression on osimertinib. Longer follow-up is needed for the modified amivantamab-lazertinib-chemotherapy regimen.Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.

基金：
Janssen Research & Development LLC. Medical writing assistance was funded by Janssen Global Services LLC. Funded by Janssen; MARIPOSA-2 (NCT04988295)
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
第一作者：
第一作者机构： [1]Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan, Italy [*1]Division of Thoracic Oncology European Institute of Oncology-IEO Via G. Ripamonti, 435-20141 Milan, Italy
共同第一作者：
通讯作者：
通讯机构： [1]Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan, Italy [*1]Division of Thoracic Oncology European Institute of Oncology-IEO Via G. Ripamonti, 435-20141 Milan, Italy
推荐引用方式(GB/T 7714)：
Passaro A,Wang Jie,Wang Y,et al.Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: Primary results from the phase 3 MARIPOSA-2 study[J].Annals of oncology : official journal of the European Society for Medical Oncology.2023,doi:10.1016/j.annonc.2023.10.117.
APA：
Passaro A,Wang Jie,Wang Y,Lee S-H,Melosky B...&Cho B C.(2023).Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: Primary results from the phase 3 MARIPOSA-2 study.Annals of oncology : official journal of the European Society for Medical Oncology,,
MLA：
Passaro A,et al."Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: Primary results from the phase 3 MARIPOSA-2 study".Annals of oncology : official journal of the European Society for Medical Oncology .(2023)

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