作者
Caicun Zhou,Gongyan Chen,Yunchao Huang,Jianying Zhou,Lizhu Lin,Jifeng Feng,Zhehai Wang,Yongqian Shu,Jianhua Shi,Yi Hu,Qiming Wang,Ying Cheng,Fengying Wu,Jianhua Chen,Xiaoyan Lin,Yongsheng Wang,Jian-An Huang,Jiuwei Cui,Lejie Cao,Yunpeng Liu,Yiping Zhang,Yueyin Pan,Jun Zhao,Liping Wang,Jianhua Chang,Qun Chen,Xiaoyan Ren,Wei Zhang,Yun Fan,He Zhou,Jian Fang,Kangsheng Gu,Xiaorong Dong,Fang Jin,Hongjun Gao,Guangyu An,Cuimin Ding,Xiaodong Jiang,Jianping Xiong,Xiangdong Zhou,Sheng Hu,Ping Lu,Anwen Liu,Shuliang Guo,Jianjin Huang,Chengchu Zhu,Jun Zhao,Beili Gao,Ying‐Lan Chen,Chengping Hu,Jian Zhang,Hongmei Zhang,Hui Zhao,Yanfei Tai,Xinjing Ma,Shi We
摘要
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.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.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.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.