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Clinical Trial
. 2023 May;18(5):628-639.
doi: 10.1016/j.jtho.2022.12.017. Epub 2023 Jan 13.

Camrelizumab Plus Carboplatin and Pemetrexed as First-Line Treatment for Advanced Nonsquamous NSCLC: Extended Follow-Up of CameL Phase 3 Trial

Caicun Zhou  1 , Gongyan Chen  2 , Yunchao Huang  3 , Jianying Zhou  4 , LiZhu Lin  5 , Jifeng Feng  6 , Zhehai Wang  7 , Yongqian Shu  8 , Jianhua Shi  9 , Yi Hu  10 , QiMing Wang  11 , Ying Cheng  12 , Fengying Wu  13 , Jianhua Chen  14 , Xiaoyan Lin  15 , Yongsheng Wang  16 , Jianan Huang  17 , Jiuwei Cui  18 , Lejie Cao  19 , Yunpeng Liu  20 , Yiping Zhang  21 , Yueyin Pan  22 , Jun Zhao  23 , LiPing Wang  24 , Jianhua Chang  25 , Qun Chen  26 , Xiubao Ren  27 , Wei Zhang  28 , Yun Fan  21 , Zhiyong He  29 , Jian Fang  30 , Kangsheng Gu  31 , XiaoRong Dong  32 , Faguang Jin  33 , Hongjun Gao  34 , Guangyu An  35 , Cuimin Ding  36 , Xiaodong Jiang  37 , Jianping Xiong  38 , Xiangdong Zhou  39 , Sheng Hu  40 , Ping Lu  41 , Anwen Liu  42 , Shuliang Guo  43 , Jianjin Huang  44 , Chengchu Zhu  45 , Jian Zhao  46 , Beili Gao  47 , Yinglan Chen  48 , Chengping Hu  49 , Jian Zhang  50 , Hongmei Zhang  51 , Hui Zhao  52 , Yanfei Tai  53 , Xinjing Ma  53 , Wei Shi  53 ; CameL Study Group
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Clinical Trial

Camrelizumab Plus Carboplatin and Pemetrexed as First-Line Treatment for Advanced Nonsquamous NSCLC: Extended Follow-Up of CameL Phase 3 Trial

Caicun Zhou et al. J Thorac Oncol. 2023 May.
Free article

Abstract

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 follow-up 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 camrelizumab 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 evidence of cumulative toxicity was found with long exposure to camrelizumab.

Conclusions: Camrelizumab plus carboplatin and pemetrexed provides long-term survival benefit over chemotherapy, with manageable toxicity and remarkable and durable response in patients receiving 2 years of camrelizumab, further supporting camrelizumab combination as first-line treatment for advanced nonsquamous NSCLC.

Keywords: Camrelizumab; Chemotherapy; Immunotherapy; Nonsquamous non–small cell lung cancer; PD-1.

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