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Efficacy and safety of GLS-010 (zimberelimab) in patients with relapsed or refractory classical Hodgkin lymphoma: A multicenter, single-arm, phase II study.

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机构: [a]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China [b]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China [c]Department of Hematology, 940 Hospital of the Joint Logistic Support Force of the PLA, Lanzhou, China [d]Department of Hematology, Beijing Hospital, Beijing, China [e]Department of Hematology, Gansu Province Cancer Hospital, Lanzhou, China [f]Department of Hematology, The Fourth Hospital of Hebei Medical University, Hebei Cancer Hospital, Shijiazhuang, China [g]Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China [h]Department of Hematology, Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, Shijiazhuang, China [i]Department of Hematology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China [j]Department of Oncology, Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology, Wuhan, China [k]Department of Medical Oncology, The Affiliate Hospital of Hebei Medical University, Baoding, China [l]Department of Lymphoma, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China [m]Department of Hematology, Jiangsu Province Hospital, Nanjing, China [n]Department of Hematology, Shengjing Hospital of China Medical University, Shenyang, China [o]Department of Hematology, The First Affiliated Hospital of Xiamen University, Xiamen, China [p]Department of Oncology, Affiliated Hospital of Guangdong Medical College, Zhanjiang, China [q]Department of Medical Oncology, Sichuan Cancer Hospital and Institute, Chengdu, China [r]Department of Hematology, Xiangya Hospital Central South University, Changsha, China [s]Department of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China [t]Department of Hematology, Peking University People’s Hospital, Beijing, China [u]Department of Lymphoma and Hematology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China [v]Department of Oncology, Cangzhou People’s Hospital, Cangzhou, China [w]Department of Hematology, Tianjin Medical University General Hospital, Tianjin, China [x]Department of Hematology and Oncology, Chongqing Cancer Hospital, Chongqing, China [y]Guangzhou Gloria Biosciences Co., Ltd., Beijing, China
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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).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).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.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.Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

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大类 | 1 区 医学
小类 | 2 区 肿瘤学
最新[2023]版:
大类 | 1 区 医学
小类 | 2 区 肿瘤学
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Q1 ONCOLOGY
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Q1 ONCOLOGY

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第一作者机构: [a]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China
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通讯机构: [a]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China [*1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The Department of Lymphoma, Peking University Cancer Hospital & Institute, No. 52, Fucheng Road, Haidian District, Beijing, 100142, China. [*2]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The Department of Lymphoma, Peking University Cancer Hospital & Institute, No. 52, Fucheng Road, Haidian District, Beijing, 100142, China.
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