Jin-Ji Yang1, Cheng Huang2, Yun Fan3, Hongming Pan4, Jifeng Feng5, Liyan Jiang6, Xing-Ya Li7, Xiao-Qing Liu8, Jian-Ping Xiong9, Yan-Qiu Zhao10, Ying Cheng11, Rui Ma12, Jie Wang13, Yina Wang14, Yan-Hui Liu15, Dong-Mei Lin16, Tao Wang17, Wei Shi17, Jianjun Zou17, Yi-Long Wu18. 1. Guangdong Lung Cancer Institute , Guangdong General Hospital & Guangdong Academy of Medical Sciences, No. 106, Zhongshan Second Road, Guangzhou, 510080, China. 2. Department of Thoracic Medical Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China. 3. Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China. 4. Department of Medical Oncology, Sir Run Run Shaw Hospital (SRRSH), Affiliated with the Zhejiang University School of Medicine, Hangzhou, China. 5. Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China. 6. Department of Pulmonary, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. 7. Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. 8. Department of Pulmonary Oncology, The Fifth Medical Centre, Chinese PLA General Hospital, Beijing, China. 9. Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China. 10. Department of Respiratory, Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. 11. Department of Internal Medicine, Jilin Cancer Hospital, Changchun, China. 12. Medical Oncology Department of Thoracic Cancer, Liaoning Cancer Hospital, Shenyang, China. 13. Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 14. Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China. 15. Department of Pathology, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China. 16. Department of Pathology, Peking University Cancer Hospital and Institute, Beijing, China. 17. Department of Clinical Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China. 18. Guangdong Lung Cancer Institute , Guangdong General Hospital & Guangdong Academy of Medical Sciences, No. 106, Zhongshan Second Road, Guangzhou, 510080, China. syylwu@live.cn.
Abstract
BACKGROUND: This phase II study evaluated camrelizumab in different PD-L1 expression cohorts of patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC; NCT03085069, registered March 21, 2017). METHODS: Patients who progressed during/after chemotherapy were enrolled and divided into four cohorts based on PD-L1 tumor proportion score (TPS). Patients with EGFR/ALK alterations and PD-L1 TPS ≥ 50% were also eligible. All enrolled patients received camrelizumab at 200 mg IV Q2W. The primary endpoint was objective response rate. RESULTS: A total of 146 patients were enrolled. As of data cutoff on Aug 20, 2020, the median follow-up was 29.5 months (95% CI 27.4-30.8). Objective response rate was 17.8% (95% CI 12.0-25.0) and improved with the increasing PD-L1 TPS (TPS < 1%, 12.2% [95% CI 5.7-21.8]; ≥ 1-< 25%, 19.4% [95% CI 7.5-37.5]; ≥ 25-< 50%, 36.4% [95% CI 10.9-69.2]; ≥ 50%, 23.3% [95% CI 9.9-42.3]). No response was observed in the five patients harboring EGFR mutations. Median progression-free survival was 3.2 months (95% CI 2.0-3.4), and patients with positive PD-L1 TPS had longer progression-free survival. Median overall survival was 14.8 months (95% CI 10.2-18.7). Treatment-related adverse events (TRAEs) of any grade occurred in 87.7% of patients, and 21.2% had grade ≥ 3 TRAEs. CONCLUSION: Camrelizumab showed improved efficacy compared with historical data of the second-line chemotherapy in pre-treated advanced/metastatic NSCLC. Patients with positive PD-L1 expression derived greater benefit from camrelizumab. Camrelizumab has a manageable safety profile.
BACKGROUND: This phase II study evaluated camrelizumab in different PD-L1 expression cohorts of patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC; NCT03085069, registered March 21, 2017). METHODS: Patients who progressed during/after chemotherapy were enrolled and divided into four cohorts based on PD-L1 tumor proportion score (TPS). Patients with EGFR/ALK alterations and PD-L1 TPS ≥ 50% were also eligible. All enrolled patients received camrelizumab at 200 mg IV Q2W. The primary endpoint was objective response rate. RESULTS: A total of 146 patients were enrolled. As of data cutoff on Aug 20, 2020, the median follow-up was 29.5 months (95% CI 27.4-30.8). Objective response rate was 17.8% (95% CI 12.0-25.0) and improved with the increasing PD-L1 TPS (TPS < 1%, 12.2% [95% CI 5.7-21.8]; ≥ 1-< 25%, 19.4% [95% CI 7.5-37.5]; ≥ 25-< 50%, 36.4% [95% CI 10.9-69.2]; ≥ 50%, 23.3% [95% CI 9.9-42.3]). No response was observed in the five patients harboring EGFR mutations. Median progression-free survival was 3.2 months (95% CI 2.0-3.4), and patients with positive PD-L1 TPS had longer progression-free survival. Median overall survival was 14.8 months (95% CI 10.2-18.7). Treatment-related adverse events (TRAEs) of any grade occurred in 87.7% of patients, and 21.2% had grade ≥ 3 TRAEs. CONCLUSION: Camrelizumab showed improved efficacy compared with historical data of the second-line chemotherapy in pre-treated advanced/metastatic NSCLC. Patients with positive PD-L1 expression derived greater benefit from camrelizumab. Camrelizumab has a manageable safety profile.