CamreliZumab Plus Carboplatin and PemetreXed as First-Line Treatment for Advanced NonsQuamous NSCLC: EXtended Follow-Up of CameL Phase 3 Trial

Zhou, Caicun; Chen, Gongyan; Huang, Yunchao; Zhou, Jianying; Lin, LiZhu; Feng, Jifeng; Wang, Zhehai; Shu, YongQian; Shi, Jianhua; Hu, Yi; Wang, QiMing; Cheng, Ying; Wu, Fengying; Chen, Jianhua; Lin, Xiaoyan; Wang, Yongsheng; Huang, Jianan; Cui, Jiuwei; Cao, Lejie; Liu, Yunpeng; Zhang, Yiping; Pan, Yueyin; Zhao, Jun; Wang, LiPing; Chang, Jianhua; Chen, Qun; Ren, Xiubao; Zhang, Wei; Fan, Yun; He, Zhiyong; Fang, Jian; Gu, Kangsheng; Dong, XiaoRong; Jin, Faguang; Gao, Hongjun; An, Guangyu

Science Citation Index Expanded

复旦大学; 广州医学院; 广州中医药大学; 安徽医科大学; 华中科技大学; 吉林大学; 南昌大学; 上海交通大学; 哈尔滨医科大学; 河北医科大学; 四川大学; 浙江大学; 郑州大学; 同济大学; 中国医科大学; 1; 5

摘要

Introduction: In CameL phase 3 study (ClinicalTrials.gov: NCT03134872), addition of camrelizumab to first-line chemotherapy significantly improved the progression-free survival in patients with stages IIIB to IV nonsquamous NSCLC. Here, we present outcomes after a minimum followup of 43.9 months since last patient randomization.Methods: Eligible patients were randomized 1:1 to 4 to 6 cycles of camrelizumab plus carboplatin and pemetrexed or chemotherapy alone every 3 weeks, followed by maintenance camrelizumab plus pemetrexed or pemetrexed only (n = 205 and 207, respectively). Total camrelizumab exposure was up to 2 years.Results: As of January 31, 2022, camrelizumab plus chemotherapy exhibited substantially improved overall survival over chemotherapy alone (median, 27.1 versus 19.8 mo; hazard ratio = 0.72 [95% confidence interval: 0.57-0.92]). In the chemotherapy-alone group, 95 patients (45.9%) crossed over to camrelizumab monotherapy. After adjustment for crossover, the survival benefit with camre-lizumab plus chemotherapy was more pronounced (adjusted hazard ratio = 0.55 [95% confidence interval: 0.42-0.71]). In camrelizumab plus chemotherapy group, 33 patients completed 2 years of camrelizumab. Objective response rate was 97.0%, with ongoing responses in 17 of the 32 responses (53.1%), and 93.9% (31 of 33) of the patients were alive at data cutoff. Safety profiles were consistent with the previous report, and no obvious evi-dence of cumulative toxicity was found with long exposure to camrelizumab.Conclusions: Camrelizumab plus carboplatin and peme-trexed provides long-term survival benefit over chemo-therapy, with manageable toxicity and remarkable and durable response in patients receiving 2 years of camreli-zumab, further supporting camrelizumab combination as first-line treatment for advanced nonsquamous NSCLC.& COPY; 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc.

关键词

Immunotherapy PD-1 Camrelizumab Chemo-therapy Nonsquamous non-small cell lung cancer