Camrelizumab plus carboplatin and pemetrexed as first-line therapy for advanced non-squamous non-small-cell lung cancer: 5-year outcomes of the CameL randomized phase 3 study

Camrelizumab plus carboplatin and pemetrexed as first-line therapy for advanced non-squamous non-small-cell lung cancer: 5-year outcomes of the CameL randomized phase 3 study

Background CameL phase 3 study demonstrated the superiority of camrelizumab plus chemotherapy over chemotherapy alone for progression-free survival in patients with previously untreated advanced non-squamous non-small-cell lung cancer (NSCLC) without EGFR/ALK alterations. Here, we present the 5-year...

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Main Authors: Jian Zhang, Ping Lu, Hui Zhao, Jianhua Chen, Wei Shi, Xiubao Ren, Yi Hu, Liping Wang, Hongmei Zhang, Chengchu Zhu, Jianping Xiong, Jianying Zhou, Jun Zhao, Yongqian Shu, Caicun Zhou, Xiaorong Dong, Yunpeng Liu, Yunchao Huang, Jian Zhao, Yiping Zhang, Sheng Hu, Xiaoyan Lin, Yueyin Pan, Jiuwei Cui, Lizhu Lin, Kangsheng Gu, Yun Fan, Qun Chen, Gongyan Chen, Zhehai Wang, Fengying Wu, Guangyu An, Shuliang Guo, Xiaodong Jiang, Yongsheng Wang, Jifeng Feng, Jianhua Shi, QiMing Wang, Jianan Huang, Lejie Cao, Jianhua Chang, Zhiyong He, Jian Fang, Faguang Jin, Hongjun Gao, Cuimin Ding, Xiangdong Zhou, Anwen Liu, Jianjin Huang, Beili Gao, Yinglan Chen, Chengping Hu, Zhigao Wang, Xinjing Ma
Format: Article
Language:English
Published: BMJ Publishing Group 2024-11-01
Series:Journal for ImmunoTherapy of Cancer
Online Access:https://jitc.bmj.com/content/12/11/e009240.full
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Summary:Background CameL phase 3 study demonstrated the superiority of camrelizumab plus chemotherapy over chemotherapy alone for progression-free survival in patients with previously untreated advanced non-squamous non-small-cell lung cancer (NSCLC) without EGFR/ALK alterations. Here, we present the 5-year outcomes.Methods Patients were randomized (1:1) and received 4–6 cycles of camrelizumab plus carboplatin and pemetrexed (n=205) or carboplatin and pemetrexed (n=207) every 3 weeks, followed by maintenance camrelizumab plus pemetrexed or pemetrexed only. Crossover from chemotherapy group to camrelizumab monotherapy was permitted after disease progression.Results Median time from randomization to data cut-off was 65.2 months (range, 59.7–72.2). HR for overall survival (OS) was 0.74 (95% CI 0.58 to 0.93; one-sided p=0.0043), and was 0.62 (95% CI 0.49 to 0.79; one-sided p<0.0001) after adjustment for crossover. Five-year OS rates were 31.2% (95% CI 24.7% to 37.9%) with camrelizumab plus chemotherapy versus 19.3% (95% CI 13.9% to 25.3%) with chemotherapy alone. Among the 33 patients who completed 2 years of camrelizumab, 5-year OS rate was 84.3% (95% CI 66.4% to 93.2%), and 5-year duration of response rate was 46.5% (95% CI 24.9% to 65.6%) in the 32 responders. No new safety signals were noted.Conclusions Camrelizumab plus carboplatin and pemetrexed as first-line therapy continued to demonstrate long-term OS benefit over carboplatin and pemetrexed, with manageable toxicity. Patients who completed 2 years of camrelizumab had enduring response and impressive OS. Current 5-year updated analysis further supports camrelizumab plus carboplatin and pemetrexed as a standard-of-care for previously untreated advanced non-squamous NSCLC without EGFR/ALK alterations.Trial registration number NCT03134872.
ISSN:2051-1426

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