Ningjing Lin1, Mingzhi Zhang2, Hai Bai3, Hui Liu4, Jie Cui5, Xiaoyan Ke6, Huilai Zhang7, Lihong Liu8, Dongmei Yan9, Yongsheng Jiang10, Aimin Zang11, Junyuan Qi12, Li Wang13, Zhuogang Liu14, Bing Xu15, Ying Zhang16, Zhihui Zhang17, Xielan Zhao18, Chunhong Hu19, Shenmiao Yang20, Hui Zhou21, Jinsheng Shi22, Zonghong Shao23, Ying Xiang24, Jiman Zhu25, Yuqin Song26, Jun Zhu27. 1. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China. 2. Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. 3. Department of Hematology, 940 Hospital of the Joint Logistic Support Force of the PLA, Lanzhou, China. 4. Department of Hematology, Beijing Hospital, Beijing, China. 5. Department of Hematology, Gansu Province Cancer Hospital, Lanzhou, China. 6. Department of Hematology, The Fourth Hospital of Hebei Medical University, Hebei Cancer Hospital, Shijiazhuang, China. 7. Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. 8. Department of Hematology, Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, Shijiazhuang, China. 9. Department of Hematology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. 10. Department of Oncology, Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology, Wuhan, China. 11. Department of Medical Oncology, The Affiliate Hospital of Hebei Medical University, Baoding, China. 12. Department of Lymphoma, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China. 13. Department of Hematology, Jiangsu Province Hospital, Nanjing, China. 14. Department of Hematology, Shengjing Hospital of China Medical University, Shenyang, China. 15. Department of Hematology, The First Affiliated Hospital of Xiamen University, Xiamen, China. 16. Department of Oncology, Affiliated Hospital of Guangdong Medical College, Zhanjiang, China. 17. Department of Medical Oncology, Sichuan Cancer Hospital and Institute, Chengdu, China. 18. Department of Hematology, Xiangya Hospital Central South University, Changsha, China. 19. Department of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China. 20. Department of Hematology, Peking University People's Hospital, Beijing, China. 21. Department of Lymphoma and Hematology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. 22. Department of Oncology, Cangzhou People's Hospital, Cangzhou, China. 23. Department of Hematology, Tianjin Medical University General Hospital, Tianjin, China. 24. Department of Hematology and Oncology, Chongqing Cancer Hospital, Chongqing, China. 25. Guangzhou Gloria Biosciences Co., Ltd., Beijing, China. 26. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China. Electronic address: songyuqin@bjmu.edu.cn. 27. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China. Electronic address: zhu-jun2017@outlook.com.
Abstract
BACKGROUND: GLS-010 (zimberelimab) is a novel, fully human, anti-programmed death-1 monoclonal antibody that shows promising efficacy and safety in advanced solid tumors. This trial aimed to evaluate the efficacy and safety of GLS-010 (zimberelimab) in Chinese patients with relapsed or refractory classical Hodgkin lymphoma (r/r-cHL). METHODS: This phase II, single-arm, open-label, multicenter clinical trial was conducted at 24 centers in China and enrolled patients with r/r-cHL after two or more lines of therapy. The patients were administered intravenous GLS-010 (zimberelimab) (240 mg, once every 2 weeks) until progression, death, unacceptable toxicity, or consent withdrawal. The primary end-point was the objective response rate assessed by an independent radiology review committee (IRC). This study was registered (NCT03655483). RESULTS: Eighty-five patients were enrolled between August 2018 and August 2019. The median follow-up was 15.8 months. Seventy-seven patients (90.6%; 95% confidence interval [CI] 82.3-95.9) had an IRC-assessed objective response. The complete response rate was 32.9% (n = 28). The 12-month progression-free survival and overall survival rates were 78% (95% CI 67.5-85.6) and 99% (95% CI 91.9-99.8), respectively. Treatment-related adverse events (TRAEs) were observed in 92.9% of participants. Grade III or IV TRAEs occurred in 24 (28.2%) of the 85 participants. The most common grade III or IV TRAEs were abnormal hepatic function (5.9%), hyperuricemia (4.7%), decreased neutrophil count (3.5%), and increased weight (3.5%). Only one grade V AE, gastrointestinal infection, occurred. CONCLUSIONS: GLS-010 (zimberelimab) appears to be effective and safe for the treatment of Chinese patients with r/r-cHL. Long-term follow-up is required to confirm these clinical benefits.
BACKGROUND: GLS-010 (zimberelimab) is a novel, fully human, anti-programmed death-1 monoclonal antibody that shows promising efficacy and safety in advanced solid tumors. This trial aimed to evaluate the efficacy and safety of GLS-010 (zimberelimab) in Chinese patients with relapsed or refractory classical Hodgkin lymphoma (r/r-cHL). METHODS: This phase II, single-arm, open-label, multicenter clinical trial was conducted at 24 centers in China and enrolled patients with r/r-cHL after two or more lines of therapy. The patients were administered intravenous GLS-010 (zimberelimab) (240 mg, once every 2 weeks) until progression, death, unacceptable toxicity, or consent withdrawal. The primary end-point was the objective response rate assessed by an independent radiology review committee (IRC). This study was registered (NCT03655483). RESULTS: Eighty-five patients were enrolled between August 2018 and August 2019. The median follow-up was 15.8 months. Seventy-seven patients (90.6%; 95% confidence interval [CI] 82.3-95.9) had an IRC-assessed objective response. The complete response rate was 32.9% (n = 28). The 12-month progression-free survival and overall survival rates were 78% (95% CI 67.5-85.6) and 99% (95% CI 91.9-99.8), respectively. Treatment-related adverse events (TRAEs) were observed in 92.9% of participants. Grade III or IV TRAEs occurred in 24 (28.2%) of the 85 participants. The most common grade III or IV TRAEs were abnormal hepatic function (5.9%), hyperuricemia (4.7%), decreased neutrophil count (3.5%), and increased weight (3.5%). Only one grade V AE, gastrointestinal infection, occurred. CONCLUSIONS: GLS-010 (zimberelimab) appears to be effective and safe for the treatment of Chinese patients with r/r-cHL. Long-term follow-up is required to confirm these clinical benefits.