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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2024-11-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Jian Zhang |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-fa2babd2caa04c86aa782e11c5e58721 |
| institution | OA Journals |
| issn | 2051-1426 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj-art-fa2babd2caa04c86aa782e11c5e587212025-08-20T01:55:30ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262024-11-01121110.1136/jitc-2024-009240Camrelizumab 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 studyJian Zhang0Ping Lu1Hui Zhao2Jianhua Chen3Wei Shi4Xiubao Ren5Yi Hu6Liping Wang7Hongmei Zhang8Chengchu Zhu9Jianping Xiong10Jianying Zhou11Jun Zhao12Yongqian Shu13Caicun Zhou14Xiaorong Dong15Yunpeng Liu16Yunchao Huang17Jian Zhao18Yiping Zhang19Sheng Hu20Xiaoyan Lin21Yueyin Pan22Jiuwei Cui23Lizhu Lin24Kangsheng Gu25Yun Fan26Qun Chen27Gongyan Chen28Zhehai Wang29Fengying Wu30Guangyu An31Shuliang Guo32Xiaodong Jiang33Yongsheng Wang34Jifeng Feng35Jianhua Shi36QiMing Wang37Jianan Huang38Lejie Cao39Jianhua Chang40Zhiyong He41Jian Fang42Faguang Jin43Hongjun Gao44Cuimin Ding45Xiangdong Zhou46Anwen Liu47Jianjin Huang48Beili Gao49Yinglan Chen50Chengping Hu51Zhigao Wang52Xinjing Ma53Department of Respiratory Medicine, The First Affiliated Hospital of Air Force Medical University, Xi’an, Shaanxi, ChinaDepartment of Medical Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China2 Department of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, Texas, USADepartment of Medical Oncology-Chest, Hunan Cancer Hospital, Changsha, Hunan, ChinaClinical Research and Development, Jiangsu Hengrui Pharmaceuticals, Shanghai, ChinaDepartment of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, ChinaOncology Department, General Hospital of Chinese People`s Liberation Army, Beijing, ChinaDepartment of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, ChinaDepartment of Medical Oncology, The First Affiliated Hospital of Air Force Medical University, Xi`an, Shaanxi, ChinaDepartment of Cardiothoracic Surgery, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, ChinaDepartment of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, ChinaRespiratory Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, ChinaDepartment of Thoracic Medical Oncology, Peking University Cancer Hospital and Institute, Beijing, ChinaDepartment of Oncology, Jiangsu Province Hospital, Nanjing, Jiangsu, ChinaDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, ChinaCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, ChinaDepartment of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, ChinaDepartment of Thoracic Surgery Oncology, Yunnan Cancer Hospital and The Third Affiliated Hospital of Kunming Medical University and Yunnan Cancer Center, Kunming, Yunnan, ChinaDepartment of Thoracic Surgical Oncology, Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, ChinaDepartment of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, ChinaDepartment of Thoracic Medicine, Hubei Cancer Hospital, Wuhan, Hubei, ChinaDepartment of Oncology, Fujian Medical University Union Hospital, Fuzhou, Fujian, ChinaDepartment of Tumor Chemotherapy, The First Affiliated Hospital University of Science Technology of China, Hefei, Anhui, ChinaDepartment of Medical Oncology, The First Bethune Hospital of Jilin University, Changchun, Jilin, ChinaOncology Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaDepartment of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, ChinaDepartment of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, ChinaDepartment of Oncology, Fuzhou Pulmonary Hospital of Fujian, Fuzhou, Fujian, ChinaDepartment of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, ChinaDepartment of Respiratory, Shandong Cancer Hospital and Institute, Jinan, Shandong, ChinaDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, ChinaDepartment of Medical Oncology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, ChinaDepartment of Respiratory Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing, ChinaDepartment of Medical Oncology, First People’s Hospital of Lianyungang City, Lianyungang, Jiangsu, ChinaDepartment of Thoracic Medical Oncology, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaDepartment of Thoracic Medical Oncology, Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research and The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of Medical Oncology, Linyi Cancer Hospital, Linyi, Shandong, ChinaRespiratory Medicine, Henan Cancer Hospital, Zhengzhou, Henan, ChinaDepartment of Respiration, First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu, ChinaPulmonary and Critical Care Medicine, The First Affiliated Hospital University of Science Technology of China, Hefei, Anhui, ChinaDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, ChinaDepartment of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, Fujian, ChinaDepartment of Thoracic Oncology II, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, ChinaDepartment of Respiratory Medicine, The Second Affiliated Hospital of Air Force Medical University, Xi`an, Shaanxi, ChinaDepartment of Pulmonary Oncology, Fifth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing, ChinaDepartment of Respiratory Medicine, The Fourth Clinical Medical College of Hebei Medical University, Shijiazhuang, Hebei, ChinaDepartment of Respiratory Medicine, First Affiliated Hospital of Army Medical University, Chongqing, Chongqing, ChinaDepartment of Medical Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, ChinaDepartment of Medical Oncology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, ChinaDepartment of Respiratory Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, ChinaDepartment of Medical Oncology, Jiangxi Cancer Hospital, Nanchang, Jiangxi, ChinaDepartment of Respiratory Medicine, Xiangya Hospital Central South University, Changsha, Hunan, ChinaClinical Research and Development, Jiangsu Hengrui Pharmaceuticals, Shanghai, ChinaClinical Research and Development, Jiangsu Hengrui Pharmaceuticals, Shanghai, ChinaBackground 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.https://jitc.bmj.com/content/12/11/e009240.full |
| spellingShingle | 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 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 Journal for ImmunoTherapy of Cancer |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://jitc.bmj.com/content/12/11/e009240.full |
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