"Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial"

作者全名:"Qin, Shukui; Li, Jin; Zhong, Haijun; Jin, Chuan; Chen, Lili; Yuan, Xianglin; Fan, Qingxia; Chen, Kehe; Cao, Peiguo; Xiao, Jianjun; Jiang, Da; Zhang, Tao; Zhang, Hongyu; Wang, Xicheng; Wang, Wei; Han, Lin; Wang, Qingyu; Zhu, Jun"

作者地址:"[Qin, Shukui] Eastern Theater Gen Hosp PLA China, Dept Oncol, Qinhuai Med Area, Nanjing, Peoples R China; [Li, Jin] Tongji Univ, Dept Oncol, Shanghai East Hosp, Shanghai, Peoples R China; [Zhong, Haijun] Univ Chinese Acad Sci, Canc Hosp, Dept Abdominal Oncol, Zhejiang Canc Hosp, Hangzhou, Peoples R China; [Jin, Chuan] Guangzhou Med Univ, Dept Oncol, Affiliated Canc Hosp & Inst, Guangzhou, Peoples R China; [Chen, Lili] Taizhou First Peoples Hosp, Dept Hematol & Oncol, Taizhou, Peoples R China; [Yuan, Xianglin] Huazhong Univ Sci & Technol, Tongji Hosp, Dept Oncol, Wuhan, Peoples R China; [Fan, Qingxia] Zhengzhou Univ, Affiliated Hosp 1, Dept Oncol, Zhengzhou, Peoples R China; [Chen, Kehe] Peoples Hosp Guangxi Zhuang Autonomous Reg, Dept Oncol, Nanning, Peoples R China; [Cao, Peiguo] Cent South Univ, Xiangya Hosp 3, Dept Oncol, Changsha, Peoples R China; [Xiao, Jianjun] Zhongshan City Peoples Hosp, Chemotherapeut Dept, Zhongshan, Peoples R China; [Jiang, Da] Hebei Med Univ, Dept Oncol, Shijiazhuang, Hebei, Peoples R China; [Zhang, Tao] Chongqing Med Univ, Affiliated Hosp 1, Dept Oncol, Chongqing, Peoples R China; [Zhang, Hongyu] Sun Yat Sen Univ, Affiliated Hosp 5, Canc Ctr, Zhuhai, Peoples R China; [Wang, Xicheng] Guangdong Pharmaceut Univ, Affiliated Hosp 1, Dept Oncol, Guangzhou, Peoples R China; [Wang, Wei] First Peoples Hosp Foshan, Dept Gastrointestinal Oncol, Foshan, Peoples R China; [Han, Lin; Wang, Qingyu; Zhu, Jun] Shanghai Henlius Biotech Inc, Shanghai, Peoples R China"

通信作者:"Li, J (通讯作者),Tongji Univ, Dept Oncol, Shanghai East Hosp, Shanghai, Peoples R China."











文献类型:Article; Early Access


摘要:"Background Microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) tumours have a high response rate to immunotherapy. Antitumour activity and safety of serplulimab, a novel humanised anti-PD-1 monoclonal antibody, were evaluated in this phase II study. Methods In this ongoing, single-arm, open-label, phase II trial, patients with previously treated unresectable or metastatic MSI-H/dMMR solid tumours received intravenous serplulimab 3 mg/kg every 2 weeks for up to 52 cycles. The primary endpoint was objective response rate (ORR) assessed by an independent radiological review committee per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included additional efficacy measures, safety, and tolerability. Results As of 9 January 2021, 108 patients were enrolled, and 68 patients with confirmed MSI-H solid tumours were included in the main efficacy analysis population (MEAP). The median follow-up duration in the MEAP was 7.7 months, with an ORR of 38.2% (95% confidence interval, 26.7-50.8). Of the 108 patients, grade >= 3 treatment-emergent adverse events were reported in 53 (49.1%) patients; immune-related adverse events occurred in 52 (48.1%) patients. Conclusions Serplulimab demonstrates a durable antitumour effect and a manageable safety profile in previously treated patients with MSI-H solid tumours. Serplulimab is a promising tissue-agnostic treatment for previously treated MSI-H solid tumours."

基金机构:"Shanghai Henlius Biotech, Inc."

基金资助正文:"This work was supported by Shanghai Henlius Biotech, Inc."