Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial
机构：[1]National Cancer Centre/ National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[2]Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China[3]Department of Lymphoma, 307th Hospital of Chinese People’s Liberation Army, Beijing, China[4]Department of Haematology, Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, Henan, China河南省肿瘤医院[5]Sun Yat-Sen University Cancer Centre, Guangzhou, Guangdong, China[6]Department of Oncology, Second Hospital of Dalian Medical University, Dalian, Liaoning[7]Department of Haematology, First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China浙江大学医学院附属第一医院[8]Department of Haematology, Peking Union Medical College Hospital, Beijing, China[9]Department of Haematology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China河北医科大学第四医院[10]Department of Haematology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China[11]Department of Haematology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China华中科技大学同济医学院附属同济医院[12]Department of Oncology, Cancer Hospital Affiliated to Guangzhou Medical University, Guangzhou, Guangdong, China[13]Department of Oncology, West China Hospital, Sichuan University, Chengdu, Sichuan, China四川大学华西医院[14]Department of Oncology, First Hospital of Jilin University, Changchun, Jilin, China[15]Department of Haematology, Changhai Hospital, Shanghai, China[16]Department of Haematology, Qilu Hospital of Shandong University, Jinan, Shandong, China[17]Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, China[18]Department of Oncology, Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, China[19]Department of Haematology, Union Hospital of Fujian Medical University, Fuzhou, Fujian, China[20]Innovent Biologics (Suzhou) Co, Suzhou, Jiangsu, China
Background Sintilimab (Innovent Biologics, Suzhou, China), a highly selective, fully humanised, monoclonal antibody, blocks the interaction between PD-1 and its ligands. We aimed to assess the activity and safety profile of sintilimab in Chinese patients with relapsed or refractory classical Hodgkin lymphoma. Pviethods In this ongoing, single-arm, phase 2 study, we recruited patients with histopathologically diagnosed classical Hodgkin lymphoma that was relapsed or refractory after two or more lines of therapy from 18 hospitals in China. Patients were given intravenous sintilimab (200 mg, once every 3 weeks) until progression, death, unacceptable toxicity, or withdrawal of consent. The primary outcome was the proportion of patients in the full analysis set (ie, those with classical Hodgkin lymphoma confirmed by the central pathology laboratory) who had an objective response, as assessed by an independent radiological review committee (IRRC), by 24 weeks after enrolment of the last patient. Tumour response was assessed by enhanced CT scan or MRI at baseline, at weeks 6, 15, and 24, every 12 weeks from weeks 24 to 48, and every 16 weeks beyond week 48. Safety was assessed in all treated patients. Findings Between April 19, 2017, and Nov 1, 2017, 96 patients were enrolled and commenced treatment. Four patients, whose diagnosis was not subsequently confirmed by the central pathology laboratory, were excluded from the full analysis set. Ten patients discontinued treatment. Median duration of follow-up was 10.5 months. In the full analysis set (n=92), 74 patients (80.4%; 95% CI 70.9-88.0) had an IRRC-assessed objective response before the analysis cutoff date of April 16, 2018. 89 (93%) of 96 patients had treatment-related adverse events, and 17 patients (18%) had grade 3 or 4 treatment-related adverse events, the most common being pyrexia (three [3%] patients). 14 (15%) patients had serious adverse events of any cause. No patient died during the study. Interpretation Sintilimab could be a new treatment option for patients with relapsed or refractory classical Hodgkin lymphoma in China. Copyright (C) 2019 Elsevier Ltd. All rights reserved.
基金：
Innovent Biologics; Eli Lilly and CompanyEli Lilly; National New Drug Innovation Programme [2014ZX09201041-001, 2017ZX09304015]; National Key Scientific Programme Precision Medicine Research Fund of China [2017YFC0909801]
第一作者机构：[1]National Cancer Centre/ National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[*1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
通讯作者：
通讯机构：[1]National Cancer Centre/ National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[*1]Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
推荐引用方式(GB/T 7714)：
Yuankai Shi,Hang Su,Yongping Song,et al.Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial[J].LANCET HAEMATOLOGY.2019,6(1):E12-E19.doi:10.1016/S2352-3026(18)30192-3.
APA：
Yuankai Shi,Hang Su,Yongping Song,Wenqi Jiang,Xiuhua Sun...&Peng Liu.(2019).Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial.LANCET HAEMATOLOGY,6,(1)
MLA：
Yuankai Shi,et al."Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial".LANCET HAEMATOLOGY 6..1(2019):E12-E19
医学