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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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单位: [1]Peking Univ Canc Hosp & Inst, Dept Lymphoma, Key Lab Carcinogenesis & Translat Res, Minist Educ Beijing, 52 Fucheng Rd, Beijing 100142, Peoples R China [2]Zhengzhou Univ, Dept Oncol, Affiliated Hosp 1, Zhengzhou, Peoples R China [3]940 Hosp Joint Logist Support Force PLA, Dept Hematol, Lanzhou, Peoples R China [4]Beijing Hosp, Dept Hematol, Beijing, Peoples R China [5]Gansu Prov Canc Hosp, Dept Hematol, Lanzhou, Peoples R China [6]Hebei Med Univ, Hebei Canc Hosp, Dept Hematol, Hosp 4, Shijiazhuang, Hebei, Peoples R China [7]Tianjin Med Univ Canc Inst & Hosp, Dept Lymphoma, Tianjin, Peoples R China [8]Hebei Med Univ, Tumor Hosp Hebei Prov, Dept Hematol, Hosp 4, Shijiazhuang, Hebei, Peoples R China [9]Xuzhou Med Univ, Dept Hematol, Affiliated Hosp, Xuzhou, Jiangsu, Peoples R China [10]Huazhong Univ Sci & Technol, Tongji Hosp, Dept Oncol, Tongji Med Coll, Wuhan, Peoples R China [11]Hebei Med Univ, Dept Med Oncol, Affiliate Hosp, Baoding, Peoples R China [12]Inst Hematol & Blood Dis Hosp, Chinese Acad Med Sci, Dept Lymphoma, Tianjin, Peoples R China [13]Jiangsu Prov Hosp, Dept Hematol, Nanjing, Peoples R China [14]China Med Univ, Dept Hematol, Shengjing Hosp, Shenyang, Peoples R China [15]Xiamen Univ, Dept Hematol, Affiliated Hosp 1, Xiamen, Peoples R China [16]Guangdong Med Coll, Dept Oncol, Affiliated Hosp, Zhanjiang, Peoples R China [17]Sichuan Canc Hosp & Inst, Dept Med Oncol, Chengdu, Peoples R China [18]Cent South Univ, Dept Hematol, Xiangya Hosp, Changsha, Peoples R China [19]Cent South Univ, Dept Oncol, Xiangya Hosp 2, Changsha, Peoples R China [20]Peking Univ Peoples Hosp, Dept Hematol, Beijing, Peoples R China [21]Cent South Univ, Xiangya Sch Med, Affiliated Canc Hosp, Dept Lymphoma & Hematol,Hunan Canc Hosp, Changsha, Peoples R China [22]Cangzhou Peoples Hosp, Dept Oncol, Cangzhou, Peoples R China [23]Tianjin Med Univ, Dept Hematol, Gen Hosp, Tianjin, Peoples R China [24]Chongqing Canc Hosp, Dept Hematol & Oncol, Chongqing, Peoples R China [25]Guangzhou Gloria Biosci Co Ltd, Beijing, Peoples R China
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关键词: Hodgkin lymphoma Treatment response Response PD-1 Monoclonal antibody

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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 Z 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.(c) 2021 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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大类 | 1 区 医学
小类 | 2 区 肿瘤学
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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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第一作者单位: [1]Peking Univ Canc Hosp & Inst, Dept Lymphoma, Key Lab Carcinogenesis & Translat Res, Minist Educ Beijing, 52 Fucheng Rd, Beijing 100142, Peoples R China
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