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

doi:10.1038/s41416-022-02001-3

	Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial
	Qin, Shukui 2; Li, Jin 3; Zhong, Haijun 4; Jin, Chuan 5; Chen, Lili 6; Yuan, Xianglin 7; Fan, Qingxia 8; Chen, Kehe 9; Cao, Peiguo 10; Xiao, Jianjun 11
刊名	BRITISH JOURNAL OF CANCER
	2022-10-19
ISSN号	0007-0920
DOI	10.1038/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.
资助项目	Shanghai Henlius Biotech, Inc.
WOS关键词	COLORECTAL-CANCER PATIENTS ; IMMUNOHISTOCHEMISTRY ; CRITERIA ; UTILITY ; RISK
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.
内容类型	期刊论文
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.Hebei Med Univ, Dept Oncol, Shijiazhuang, Hebei, Peoples R China 2.Eastern Theater Gen Hosp PLA China, Dept Oncol, Qinhuai Med Area, Nanjing, Peoples R China 3.Tongji Univ, Dept Oncol, Shanghai East Hosp, Shanghai, Peoples R China 4.Univ Chinese Acad Sci, Canc Hosp, Dept Abdominal Oncol, Zhejiang Canc Hosp, Hangzhou, Peoples R China 5.Guangzhou Med Univ, Dept Oncol, Affiliated Canc Hosp & Inst, Guangzhou, Peoples R China 6.Taizhou First Peoples Hosp, Dept Hematol & Oncol, Taizhou, Peoples R China 7.Huazhong Univ Sci & Technol, Tongji Hosp, Dept Oncol, Wuhan, Peoples R China 8.Zhengzhou Univ, Affiliated Hosp 1, Dept Oncol, Zhengzhou, Peoples R China 9.Peoples Hosp Guangxi Zhuang Autonomous Reg, Dept Oncol, Nanning, Peoples R China 10.Cent South Univ, Xiangya Hosp 3, Dept Oncol, Changsha, 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).