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Camrelizumab for relapsed or refractory classical Hodgkin lymphoma: Extended follow-up of the multicenter, single-arm, Phase 2 study.

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机构: [1]Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing,China [2]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute,Beijing, China [3]Department of Hematology, West China Hospital, Sichuan University, Chengdu, China [4]Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China [5]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China [6]Lymphatic Comprehensive Internal Medicine Ward, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China [7]Lymphoma Clinic, Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjing, China [8]Department of Hematology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China [9]Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China [10]Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, China [11]Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China [12]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [13]Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, China [14]Department of Oncology, Cancer Hospital Harbin Medical University, Harbin, China [15]Department of Oncology, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China [16]Department of Clinical Statistics and Programming, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China
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关键词: camrelizumab classical Hodgkin lymphoma long-term follow-up PD-1 Phase 2 clinical trial

摘要:
Camrelizumab (a humanized high-affinity IgG4 mAb against programmed death-l) showed potent antitumor activity, well tolerance and controllable safety in patients with relapsed or refractory classical Hodgkin lymphoma (r/r cHL), based on the primary analysis of a Phase 2 study. Here, we present the extended follow-up outcomes. Seventy-five patients who had failed to achieve a remission or experienced progression after autologous stem cell transplantation or had received at least two lines of systemic chemotherapies were enrolled to receive camrelizumab 200 mg every 2 weeks. With a median follow-up of 36.2 months (range, 7.2-38.1), objective response rate per independent central review was 76.0% (95% confidence interval [CI], 64.7-85.1). Among the 57 responders, 31 (54.4%) had ongoing responses. Median duration of response was 31.7 months (95% CI, 16.7-not reached). Median progression-free survival was 22.5 months (95% CI, 14.7-not reached). Thirty-six-month overall survival rate was 82.7% (95% CI, 72.0-89.5). Reactive capillary endothelial proliferation (RCEP) occurred in 97.3% of patients (73/75), but all RCEP were Grade 1 or 2 in severity and 67.1% of these patients (49/73) achieved complete resolution. Occurrence of new RCEP lesions was rare (8/42 [19.0%] at 12 months; 2/32 [6.3%] at 24 months). No treatment-related deaths occurred, and no new toxicities were reported. With extended follow-up, camrelizumab monotherapy continues to provide a robust and durable response, long survival and manageable safety in r/r cHL patients.© 2021 UICC.

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出版当年[2021]版:
大类 | 1 区 医学
小类 | 2 区 肿瘤学
最新[2023]版:
大类 | 2 区 医学
小类 | 2 区 肿瘤学
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第一作者机构: [1]Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing,China
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通讯机构: [1]Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing,China [2]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute,Beijing, China [*1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, No. 52, Fucheng Road, Haidian District, Beijing 100142, China. [*2]Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baiziting,Nanjing, China
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