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Treatment of relapsed or refractory classical Hodgkin lymphoma with the anti-PD-1, tislelizumab: results of a phase 2, single-arm, multicenter study

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机构: [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China [2]Department of Immunotherapy, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China [3]Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, Tianjin, China [4]Department of Hematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing, China [5]Department of Hematology, Tongji Hospital, Tongji Medical College, Wuhan, China [6]State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China [7]Department of Hematology, Cancer Center, The First Hospital of Jilin University, Changchun, China [8]Department of Oncology, Zhejiang Cancer Hospital, Hangzhou, China [9]Department of Hematology, West China Hospital of Sichuan University, Chengdu, China [10]Department of Hematology, Chinese PLA General Hospital, Beijing, China [11]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China [12]BeiGene (Beijing) Co., Ltd., Beijing, China [13]BeiGene USA, Inc., San Mateo, CA, USA
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Prognosis is poor for patients with relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL) after failure of or who are ineligible for autologous stem cell transplant. We evaluated the efficacy and safety of tislelizumab, an investigational antiPD-1 monoclonal antibody, in phase 2, single-arm study in Chinese patients with R/R cHL. The primary endpoint was overall response rate as assessed by an independent review committee, according to the Lugano 2014 Classification. Seventy patients were enrolled in the study and received at least one dose of tislelizumab. After median follow-up of 9.8 months, 61 (87.1%) patients achieved an objective response, with 44 (62.9%) achieving a complete response (CR). The estimated 9-month progression-free survival rate was 74.5%. Most common grade >= 3 adverse events (AEs) were upper respiratory tract infection and pneumonitis. Infusion-related reactions occurred in 27 (38.6%) patients, and 27 patients (38.6%) experienced an immune-related AE, the most common of which was thyroid dysfunction. Eleven (15.7%) patients experienced at least one treatment-emergent AE leading to dose interruption or delay. No deaths occurred due to AEs. Treatment of patients with R/R cHL with tislelizumab was generally well tolerated and resulted in high overall response and CR rates, potentially translating into more durable responses for these patients.

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出版当年[2020]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 血液学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 血液学 1 区 肿瘤学
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出版当年[2020]版:
Q1 ONCOLOGY Q1 HEMATOLOGY
最新[2023]版:
Q1 HEMATOLOGY Q1 ONCOLOGY

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第一作者机构: [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China
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