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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 III MARIPOSA-2 study

医学 化疗 卡铂 培美曲塞 内科学 肿瘤科 化疗方案 肺癌 危险系数 奥西默替尼 无进展生存期 临床研究阶段 养生 癌症 顺铂 埃罗替尼 表皮生长因子受体 置信区间
作者
Antonio Passaro,Jie Wang,Yan Wang,S.-H. Lee,Barbara Melosky,Jin‐Yuan Shih,Jialei Wang,Keisuke Azuma,O. Juan-Vidal,Manuel Cobo,Enriqueta Felip,Nicolas Girard,A. Cortot,Raffaele Califano,Federico Cappuzzo,Scott Owen,Sanjay Popat,Ju Le Tan,Jorge Salinas,Pascale Tomasini,Ryan D. Gentzler,W.N. William,Karen L. Reckamp,Toshiaki Takahashi,Sandip Ganguly,Dariusz M. Kowalski,Alessandra Bearz,Melanie Mackean,P. Barala,A.B. Bourla,Angela Girvin,James Greger,Dawn Millington,M. Withelder,John Xie,Tao Sun,Shalin Shah,B. Diorio,Roland Knoblauch,Joshua Bauml,Rosario García Campelo,Byoung Chul Cho
出处
期刊:Annals of Oncology [Elsevier]
卷期号:35 (1): 77-90 被引量:15
标识
DOI:10.1016/j.annonc.2023.10.117
摘要

BackgroundAmivantamab 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.Patients and methodsA 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.ResultsAll 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.ConclusionsAmivantamab-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.
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