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

HFCAS OpenIR

	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 1; Li, Jin 2; Zhong, Haijun 3; Jin, Chuan 4; Chen, Lili 5; Yuan, Xianglin 6; Fan, Qingxia 7; Chen, Kehe 8; Cao, Peiguo 9; Xiao, Jianjun 10; Jiang, Da 11; Zhang, Tao12 ; Zhang, Hongyu 13; Wang, Xicheng 14; Wang, Wei15 ; Han, Lin 16; Wang, Qingyu 16; Zhu, Jun 16
	2022-10-19
发表期刊	BRITISH JOURNAL OF CANCER
ISSN	0007-0920
通讯作者	Li, Jin(lijin@csco.org.cn)
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.
DOI	10.1038/s41416-022-02001-3
关键词[WOS]	COLORECTAL-CANCER PATIENTS ; IMMUNOHISTOCHEMISTRY ; CRITERIA ; UTILITY ; RISK
收录类别	SCI
语种	英语
资助项目	Shanghai Henlius Biotech, Inc.
项目资助者	Shanghai Henlius Biotech, Inc.
WOS研究方向	Oncology
WOS类目	Oncology
WOS记录号	WOS:000870104200003
出版者	SPRINGERNATURE
引用统计	被引频次：12[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	http://ir.hfcas.ac.cn:8080/handle/334002/129467
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.Eastern Theater Gen Hosp PLA China, Dept Oncol, Qinhuai Med Area, Nanjing, Peoples R China 2.Tongji Univ, Dept Oncol, Shanghai East Hosp, Shanghai, Peoples R China 3.Univ Chinese Acad Sci, Canc Hosp, Dept Abdominal Oncol, Zhejiang Canc Hosp, Hangzhou, Peoples R China 4.Guangzhou Med Univ, Dept Oncol, Affiliated Canc Hosp & Inst, Guangzhou, Peoples R China 5.Taizhou First Peoples Hosp, Dept Hematol & Oncol, Taizhou, Peoples R China 6.Huazhong Univ Sci & Technol, Tongji Hosp, Dept Oncol, Wuhan, Peoples R China 7.Zhengzhou Univ, Affiliated Hosp 1, Dept Oncol, Zhengzhou, Peoples R China 8.Peoples Hosp Guangxi Zhuang Autonomous Reg, Dept Oncol, Nanning, Peoples R China 9.Cent South Univ, Xiangya Hosp 3, Dept Oncol, Changsha, Peoples R China 10.Zhongshan City Peoples Hosp, Chemotherapeut Dept, Zhongshan, Peoples R China 11.Hebei Med Univ, Dept Oncol, Shijiazhuang, Hebei, Peoples R China 12.Chongqing Med Univ, Affiliated Hosp 1, Dept Oncol, Chongqing, Peoples R China 13.Sun Yat Sen Univ, Affiliated Hosp 5, Canc Ctr, Zhuhai, Peoples R China 14.Guangdong Pharmaceut Univ, Affiliated Hosp 1, Dept Oncol, Guangzhou, Peoples R China 15.First Peoples Hosp Foshan, Dept Gastrointestinal Oncol, Foshan, Peoples R China 16.Shanghai Henlius Biotech Inc, Shanghai, 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).