Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4)  

作　　者：Rong Tao Lei Fan Yongping Song Yu Hu Wei Zhang Yafei Wang Wei Xu Jianyong Li 

机构地区：[1]Department of Hematology,Xinhua Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China [2]The First Affiliated Hospital of Nanjing Medical University,Jiangsu Province Hospital,Collaborative Innovation Center for Cancer Personalized Medicine,Nanjing,China [3]The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital,Zhengzhou,China [4]Union Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan,China [5]Peking Union Medical College Hospital,Beijing,China [6]Tianjin Medical University Cancer Institute and Hospital,Tianjin,China

出　　处：《Signal Transduction and Targeted Therapy》2021年第11期3341-3347,共7页信号转导与靶向治疗（英文）

基　　金：This trial was supported by the National Natural Science Foundation of China(81720108002);the National Science and Technology Major Project(2018ZX09734-007);Excellent Youth Foundation Project of Jiangsu Province(Grant No.BK20160099);Translational Research Grant of NCRCH(2020ZKZB01);CSCO Research Foundation(Y-Roche2019/2-0090).

摘　　要：This study(ORIENT-4)aimed to assess the efficacy and safety of sintilimab,a humanized anti-PD-1 antibody,in patients with relapsed/refractory extranodal NK/T cell lymphoma(r/r ENKTL).ORIENT-4 is a multicenter,single-arm,phase 2 clinical trial(NCT03228836).Patients with r/r ENKTL who failed to at least one asparaginase-based regimen were enrolled to receive sintilimab 200 mg intravenously every 3 weeks for up to 24 months.The primary endpoint was the objective response rate(ORR)based on Lugano 2014 criteria.Twenty-eight patients with r/r ENKTL were enrolled from August 31,2017 to February 7,2018.Twenty-one patients(75.0%,95%CI:55.1–89.3%)achieved an objective response.With a median follow-up of 30.4 months,the median overall survival(OS)was not reached.The 24-month OS rate was 78.6%(95%CI,58.4–89.8%).Most treatment-related adverse events(TRAEs)were grade 1–2(71.4%),and the most common TRAE was decreased lymphocyte count(42.9%).Serious adverse events(SAEs)occurred in 7(25.0%)patients,and no patient died of adverse events.Sintilimab is effective and well tolerated in patients with r/r ENKTL and could be a novel therapeutic approach for the control of ENKTL in patients.

关 键 词：lymphoma RELAPSE NODAL 

分 类 号：R733[医药卫生—肿瘤]