{"title":"Camrelizumab联合卡铂和培美曲塞作为晚期非鳞状非小细胞肺癌的一线治疗:CameL随机3期研究的5年结果","authors":"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, Jianan Huang, Jiuwei Cui, Lejie Cao, Yunpeng Liu, Yiping Zhang, Yueyin Pan, Jun Zhao, LiPing Wang, Jianhua Chang, Qun Chen, Xiubao Ren, Wei Zhang, Yun Fan, Zhiyong He, Jian Fang, Kangsheng Gu, XiaoRong Dong, Faguang 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, Jian Zhao, Beili Gao, Yinglan Chen, Chengping Hu, Jian Zhang, Hongmei Zhang, Hui Zhao, Zhigao Wang, Xinjing Ma, Wei Shi","doi":"10.1136/jitc-2024-009240","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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 <i>EGFR</i>/<i>ALK</i> alterations. Here, we present the 5-year outcomes.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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 <i>EGFR</i>/<i>ALK</i> alterations.</p><p><strong>Trial registration number: </strong>NCT03134872.</p>","PeriodicalId":14820,"journal":{"name":"Journal for Immunotherapy of Cancer","volume":"12 11","pages":""},"PeriodicalIF":10.3000,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603811/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"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, Jianan Huang, Jiuwei Cui, Lejie Cao, Yunpeng Liu, Yiping Zhang, Yueyin Pan, Jun Zhao, LiPing Wang, Jianhua Chang, Qun Chen, Xiubao Ren, Wei Zhang, Yun Fan, Zhiyong He, Jian Fang, Kangsheng Gu, XiaoRong Dong, Faguang 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, Jian Zhao, Beili Gao, Yinglan Chen, Chengping Hu, Jian Zhang, Hongmei Zhang, Hui Zhao, Zhigao Wang, Xinjing Ma, Wei Shi\",\"doi\":\"10.1136/jitc-2024-009240\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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 <i>EGFR</i>/<i>ALK</i> alterations. Here, we present the 5-year outcomes.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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 <i>EGFR</i>/<i>ALK</i> alterations.</p><p><strong>Trial registration number: </strong>NCT03134872.</p>\",\"PeriodicalId\":14820,\"journal\":{\"name\":\"Journal for Immunotherapy of Cancer\",\"volume\":\"12 11\",\"pages\":\"\"},\"PeriodicalIF\":10.3000,\"publicationDate\":\"2024-11-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603811/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal for Immunotherapy of Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/jitc-2024-009240\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal for Immunotherapy of Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/jitc-2024-009240","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:CameL iii期研究表明,camrelizumab联合化疗比单独化疗更能提高未接受EGFR/ALK改变的晚期非鳞状非小细胞肺癌(NSCLC)患者的无进展生存期。在这里,我们展示了5年的结果。方法:患者以1:1的比例随机分组,每3周接受4-6个周期的camrelizumab +卡铂+培美曲塞(n=205)或卡铂+培美曲塞(n=207),随后进行camrelizumab +培美曲塞或仅培美曲塞的维持治疗。在疾病进展后,允许从化疗组切换到camrelizumab单药治疗。结果:从随机分组到数据截止的中位时间为65.2个月(范围59.7-72.2)。总生存期(OS)的HR为0.74 (95% CI 0.58 ~ 0.93;单侧p=0.0043),为0.62 (95% CI 0.49 ~ 0.79;单侧结论:Camrelizumab联合卡铂和培美曲塞作为一线治疗继续显示出长期的OS优于卡铂和培美曲塞,毒性可控。完成2年camrelizumab治疗的患者有持久的反应和令人印象深刻的OS。目前的5年更新分析进一步支持camrelizumab联合卡铂和培美曲塞作为先前未治疗的晚期非鳞状NSCLC的标准治疗,无EGFR/ALK改变。试验注册号:NCT03134872。
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 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.
期刊介绍:
The Journal for ImmunoTherapy of Cancer (JITC) is a peer-reviewed publication that promotes scientific exchange and deepens knowledge in the constantly evolving fields of tumor immunology and cancer immunotherapy. With an open access format, JITC encourages widespread access to its findings. The journal covers a wide range of topics, spanning from basic science to translational and clinical research. Key areas of interest include tumor-host interactions, the intricate tumor microenvironment, animal models, the identification of predictive and prognostic immune biomarkers, groundbreaking pharmaceutical and cellular therapies, innovative vaccines, combination immune-based treatments, and the study of immune-related toxicity.