Journal for ImmunoTherapy of Cancer (Nov 2024)
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
- 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
Affiliations
- Jian Zhang
- Department of Respiratory Medicine, The First Affiliated Hospital of Air Force Medical University, Xi’an, Shaanxi, China
- Ping Lu
- Department of Medical Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
- Hui Zhao
- 2 Department of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
- Jianhua Chen
- Department of Medical Oncology-Chest, Hunan Cancer Hospital, Changsha, Hunan, China
- Wei Shi
- Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals, Shanghai, China
- Xiubao Ren
- Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
- Yi Hu
- Oncology Department, General Hospital of Chinese People`s Liberation Army, Beijing, China
- Liping Wang
- Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
- Hongmei Zhang
- Department of Medical Oncology, The First Affiliated Hospital of Air Force Medical University, Xi`an, Shaanxi, China
- Chengchu Zhu
- Department of Cardiothoracic Surgery, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China
- Jianping Xiong
- Department of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
- Jianying Zhou
- Respiratory Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China
- Jun Zhao
- Department of Thoracic Medical Oncology, Peking University Cancer Hospital and Institute, Beijing, China
- Yongqian Shu
- Department of Oncology, Jiangsu Province Hospital, Nanjing, Jiangsu, China
- Caicun Zhou
- Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
- Xiaorong Dong
- Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
- Yunpeng Liu
- Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China
- Yunchao Huang
- Department of Thoracic Surgery Oncology, Yunnan Cancer Hospital and The Third Affiliated Hospital of Kunming Medical University and Yunnan Cancer Center, Kunming, Yunnan, China
- Jian Zhao
- Department of Thoracic Surgical Oncology, Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, China
- Yiping Zhang
- Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
- Sheng Hu
- Department of Thoracic Medicine, Hubei Cancer Hospital, Wuhan, Hubei, China
- Xiaoyan Lin
- Department of Oncology, Fujian Medical University Union Hospital, Fuzhou, Fujian, China
- Yueyin Pan
- Department of Tumor Chemotherapy, The First Affiliated Hospital University of Science Technology of China, Hefei, Anhui, China
- Jiuwei Cui
- Department of Medical Oncology, The First Bethune Hospital of Jilin University, Changchun, Jilin, China
- Lizhu Lin
- Oncology Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
- Kangsheng Gu
- Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
- Yun Fan
- Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
- Qun Chen
- Department of Oncology, Fuzhou Pulmonary Hospital of Fujian, Fuzhou, Fujian, China
- Gongyan Chen
- Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
- Zhehai Wang
- Department of Respiratory, Shandong Cancer Hospital and Institute, Jinan, Shandong, China
- Fengying Wu
- Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
- Guangyu An
- Department of Medical Oncology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
- Shuliang Guo
- Department of Respiratory Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing, China
- Xiaodong Jiang
- Department of Medical Oncology, First People’s Hospital of Lianyungang City, Lianyungang, Jiangsu, China
- Yongsheng Wang
- Department of Thoracic Medical Oncology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
- Jifeng Feng
- Department of Thoracic Medical Oncology, Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research and The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
- Jianhua Shi
- Department of Medical Oncology, Linyi Cancer Hospital, Linyi, Shandong, China
- QiMing Wang
- Respiratory Medicine, Henan Cancer Hospital, Zhengzhou, Henan, China
- Jianan Huang
- Department of Respiration, First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu, China
- Lejie Cao
- Pulmonary and Critical Care Medicine, The First Affiliated Hospital University of Science Technology of China, Hefei, Anhui, China
- Jianhua Chang
- Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Zhiyong He
- Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, Fujian, China
- Jian Fang
- Department of Thoracic Oncology II, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China
- Faguang Jin
- Department of Respiratory Medicine, The Second Affiliated Hospital of Air Force Medical University, Xi`an, Shaanxi, China
- Hongjun Gao
- Department of Pulmonary Oncology, Fifth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing, China
- Cuimin Ding
- Department of Respiratory Medicine, The Fourth Clinical Medical College of Hebei Medical University, Shijiazhuang, Hebei, China
- Xiangdong Zhou
- Department of Respiratory Medicine, First Affiliated Hospital of Army Medical University, Chongqing, Chongqing, China
- Anwen Liu
- Department of Medical Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
- Jianjin Huang
- Department of Medical Oncology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China
- Beili Gao
- Department of Respiratory Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
- Yinglan Chen
- Department of Medical Oncology, Jiangxi Cancer Hospital, Nanchang, Jiangxi, China
- Chengping Hu
- Department of Respiratory Medicine, Xiangya Hospital Central South University, Changsha, Hunan, China
- Zhigao Wang
- Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals, Shanghai, China
- Xinjing Ma
- Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals, Shanghai, China
- DOI
- https://doi.org/10.1136/jitc-2024-009240
- Journal volume & issue
-
Vol. 12,
no. 11
Abstract
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.
