Yun Fan1, Jun Zhao2, Qiming Wang3, Dingzhi Huang4, Xingya Li5, Jianhua Chen6, Yong Fang7, Jianchun Duan8, Caicun Zhou9, Yanping Hu10, Haihua Yang11, Yi Hu12, Jianying Zhou13, Xiaoyan Lin14, Lifeng Wang15, Zhijie Wang8, Yanjun Xu1, Tao Zhang16, Wei Shi16, Jianjun Zou16, Jie Wang17. 1. Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, People's Republic of China. 2. Department of Thoracic Medical Oncology, Beijing Cancer Hospital, Beijing, People's Republic of China. 3. Department of Internal Medicine, Henan Cancer Hospital, Zhengzhou, People's Republic of China. 4. Department of Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China. 5. Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People's Republic of China. 6. Department of Medical Oncology, Hunan Cancer Hospital, Changsha, People's Republic of China. 7. Department of Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China. 8. Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, People's Republic of China. 9. Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China. 10. Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, People's Republic of China. 11. Department of Radiotherapy Section, Taizhou Hospital of Zhejiang Province, Taizhou, People's Republic of China. 12. Department of Medical Oncology, Chinese PLA General Hospital, Beijing, People's Republic of China. 13. Department of Respiratory Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou, People's Republic of China. 14. Department of Oncology, Fujian Medical University Union Hospital, Fuzhou, People's Republic of China. 15. Department of Medical Oncology, Drum Tower Hospital Affiliated to Medical School of Nanjing University, Nanjing, People's Republic of China. 16. Hengrui Medicine, Shanghai, People's Republic of China. 17. Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, People's Republic of China. Electronic address: zlhuxi@163.com.
Abstract
INTRODUCTION: Treatment options in the second-line extensive-stage SCLC (ED-SCLC) setting are limited. The PASSION study (ClinicalTrials.gov identifier: NCT03417895) was a phase 2 study of camrelizumab plus apatinib in ED-SCLC after platinum-based chemotherapy. METHODS: In stage I of the study, patients were randomized (1:1:1) to receive camrelizumab 200 mg every 2 weeks plus apatinib 375 mg once daily (QD), 5 days on and 2 days off, or 7 days on and 7 days off (six patients each cohort). On the basis of tolerability during the first 28-day cycle and efficacy data at stage I, one cohort was chosen to expand to 45 patients at stage II. The primary end point was objective response rate (ORR). RESULTS:From April 20, 2018 to March 12, 2019, a total of 59 patients were enrolled, with 47 patients in the QD cohort. In the QD cohort, confirmed ORR reached 34.0% (95% confidence interval: 20.9‒49.3), the median progression-free survival was 3.6 months, and the median overall survival was 8.4 months. Chemotherapy-sensitive and chemotherapy-resistant patients (defined as patients with disease relapse at ≥90 and <90 d after platinum-based chemotherapy, respectively) had comparable confirmed ORR (37.5% versus 32.3%), median progression-free survival (3.6 versus 2.7 mo), and median overall survival (9.6 versus 8.0 mo). Treatment-related adverse events of grade 3 or higher were reported in 43 of 59 patients (72.9%). Five patients (8.5%) discontinued because of treatment-related adverse events. CONCLUSIONS:Camrelizumab plus apatinib exhibited potential antitumor activity in patients with both chemotherapy-sensitive and chemotherapy-resistant ED-SCLC who had failed platinum-based chemotherapy with an acceptable toxicity profile. This phase 2 data warrant further clinical studies of camrelizumab plus apatinib in SCLC.
RCT Entities:
INTRODUCTION: Treatment options in the second-line extensive-stage SCLC (ED-SCLC) setting are limited. The PASSION study (ClinicalTrials.gov identifier: NCT03417895) was a phase 2 study of camrelizumab plus apatinib in ED-SCLC after platinum-based chemotherapy. METHODS: In stage I of the study, patients were randomized (1:1:1) to receive camrelizumab 200 mg every 2 weeks plus apatinib 375 mg once daily (QD), 5 days on and 2 days off, or 7 days on and 7 days off (six patients each cohort). On the basis of tolerability during the first 28-day cycle and efficacy data at stage I, one cohort was chosen to expand to 45 patients at stage II. The primary end point was objective response rate (ORR). RESULTS: From April 20, 2018 to March 12, 2019, a total of 59 patients were enrolled, with 47 patients in the QD cohort. In the QD cohort, confirmed ORR reached 34.0% (95% confidence interval: 20.9‒49.3), the median progression-free survival was 3.6 months, and the median overall survival was 8.4 months. Chemotherapy-sensitive and chemotherapy-resistant patients (defined as patients with disease relapse at ≥90 and <90 d after platinum-based chemotherapy, respectively) had comparable confirmed ORR (37.5% versus 32.3%), median progression-free survival (3.6 versus 2.7 mo), and median overall survival (9.6 versus 8.0 mo). Treatment-related adverse events of grade 3 or higher were reported in 43 of 59 patients (72.9%). Five patients (8.5%) discontinued because of treatment-related adverse events. CONCLUSIONS: Camrelizumab plus apatinib exhibited potential antitumor activity in patients with both chemotherapy-sensitive and chemotherapy-resistant ED-SCLC who had failed platinum-based chemotherapy with an acceptable toxicity profile. This phase 2 data warrant further clinical studies of camrelizumab plus apatinib in SCLC.
Authors: Li Wang; Xiaomo Li; Yurong Cheng; Jing Yang; Si Liu; Tonghui Ma; Li Luo; Yanping Hu; Yi Cai; Dong Yan Journal: Front Immunol Date: 2022-01-06 Impact factor: 7.561