中国科学院机构知识库网格
Chinese Academy of Sciences Institutional Repositories Grid
首页 机构 成果 学者
  
  1. CAS IR Grid
  2. 合肥物质科学研究院
  3. 中国科学院合肥物质科学研究院
Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial

文献类型：期刊论文

作者Qin, Shukui8; Li, Jin9; Zhong, Haijun10; Jin, Chuan11; Chen, Lili12; Yuan, Xianglin13; Fan, Qingxia14; Chen, Kehe15; Cao, Peiguo1; Xiao, Jianjun16
刊名BRITISH JOURNAL OF CANCER
出版日期2022-10-19
ISSN号0007-0920
DOI10.1038/s41416-022-02001-3
通讯作者Li, Jin(lijin@csco.org.cn)
英文摘要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.
WOS关键词COLORECTAL-CANCER PATIENTS ; IMMUNOHISTOCHEMISTRY ; CRITERIA ; UTILITY ; RISK
资助项目Shanghai Henlius Biotech, Inc.
WOS研究方向Oncology
语种英语
出版者SPRINGERNATURE
WOS记录号WOS:000870104200003
资助机构Shanghai Henlius Biotech, Inc.
源URL[http://ir.hfcas.ac.cn:8080/handle/334002/129466]  
专题中国科学院合肥物质科学研究院
通讯作者Li, Jin
作者单位1.Cent South Univ, Xiangya Hosp 3, Dept Oncol, Changsha, Peoples R China
2.Shanghai Henlius Biotech Inc, Shanghai, Peoples R China
3.First Peoples Hosp Foshan, Dept Gastrointestinal Oncol, Foshan, Peoples R China
4.Guangdong Pharmaceut Univ, Affiliated Hosp 1, Dept Oncol, Guangzhou, Peoples R China
5.Sun Yat Sen Univ, Affiliated Hosp 5, Canc Ctr, Zhuhai, Peoples R China
6.Chongqing Med Univ, Affiliated Hosp 1, Dept Oncol, Chongqing, Peoples R China
7.Hebei Med Univ, Dept Oncol, Shijiazhuang, Hebei, Peoples R China
8.Eastern Theater Gen Hosp PLA China, Dept Oncol, Qinhuai Med Area, Nanjing, Peoples R China
9.Tongji Univ, Dept Oncol, Shanghai East Hosp, Shanghai, Peoples R China
10.Univ Chinese Acad Sci, Canc Hosp, Dept Abdominal Oncol, Zhejiang Canc Hosp, Hangzhou, Peoples R China
推荐引用方式
GB/T 7714		 Qin, Shukui,Li, Jin,Zhong, Haijun,et al. Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial[J]. BRITISH JOURNAL OF CANCER,2022.
APA Qin, Shukui.,Li, Jin.,Zhong, Haijun.,Jin, Chuan.,Chen, Lili.,...&Zhu, Jun.(2022).Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial.BRITISH JOURNAL OF CANCER.
MLA Qin, Shukui,et al."Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial".BRITISH JOURNAL OF CANCER (2022).

入库方式： OAI收割

来源：合肥物质科学研究院

浏览0
下载0
收藏0
其他版本

除非特别说明，本系统中所有内容都受版权保护，并保留所有权利。