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Tislelizumab in previously treated, locally advanced unresectable/metastatic microsatellite instability-high/ mismatch repair-deficient solid tumors

文献类型：期刊论文

作者Li, Jian22; Xu, Ye21; Zang, Aimin20; Gao, Yunong19; Gao, Quanli18; Zhang, Yanqiao17; Wang, Dong16; Xu, Jianming5; Yuan, Ying7; Jiang, Haiping8
刊名CHINESE JOURNAL OF CANCER RESEARCH
出版日期2024-06-01
卷号36
关键词Biomarkers DNA mismatch repair immune checkpoint inhibitors microsatellite instability phase II clinical trials programmed cell death 1 receptor
ISSN号1000-9604
DOI10.21147/j.issn.1000-9604.2024.03.03
通讯作者Li, Jian(oncogene@163.com) ; Shen, Lin(linshenpku@163.com)
英文摘要Objective: The open-label, phase II RATIONALE-209 study evaluated tislelizumab (anti-programmed cell death protein 1 antibody) as a tissue-agnostic monotherapy for microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) tumors. Methods: Adults with previously treated, locally advanced unresectable or metastatic MSI-H/dMMR solid tumors were enrolled. Patients received tislelizumab 200 mg intravenously every 3 weeks. Objective response rate (ORR; primary endpoint), duration of response (DoR), and progression-free survival (PFS) were assessed by independent review committee (Response Evaluation Criteria in Solid Tumors v1.1). Results: Eighty patients were enrolled and treated; 75 (93.8%) patients had measurable disease at baseline. Most had metastatic disease and received at least one prior therapy for advanced/metastatic disease (n=79; 98.8%). At primary analysis (data cutoff July 8, 2021; median follow-up 15.2 months), overall ORR [46.7%; 95% confidence interval (95% CI), 35.1 -58.6; one-sided P<0.0001] and ORR across tumor-specific subgroups [colorectal (n=46): 39.1% (95% CI, 25.1-54.6); gastric/gastroesophageal junction (n=9): 55.6% (95% CI, 21.2 -86.3); others (n=20): 60.0% (95% CI, 36.1 -80.9)] were significantly greater with tislelizumab vs. a prespecified historical control ORR of 10%; five (6.7%) patients had complete responses. Median DoR, PFS, and overall survival were not reached with long-term follow-up (data cutoff December 5, 2022; median follow-up 28.9 months). Tislelizumab was well tolerated with no unexpected safety signals. Treatment-related adverse events (TRAEs) of grade >= 3 occurred in 53.8% of patients; 7.5% of patients discontinued treatment due to TRAEs. Conclusions: Tislelizumab demonstrated a significant ORR improvement in patients with previously treated, locally advanced unresectable or metastatic MSI-H/dMMR tumors and was generally well tolerated.
WOS关键词COLORECTAL-CANCER ; PLACEBO ; TRIAL
资助项目BeiGene
WOS研究方向Oncology
语种英语
WOS记录号WOS:001266448200003
出版者CHINESE JOURNAL CANCER RESEARCH CO
资助机构BeiGene
源URL[http://ir.hfcas.ac.cn:8080/handle/334002/137021]  
专题中国科学院合肥物质科学研究院
通讯作者Li, Jian; Shen, Lin
作者单位1.Anhui Prov Hosp, Dept Med Oncol, Hefei 230001, Peoples R China
2.Jilin Canc Hosp, Dept Med Oncol, Changchun 130012, Peoples R China
3.Hubei Canc Hosp, Dept Med Oncol, Wuhan 430079, Peoples R China
4.BeiGene Shanghai Co Ltd, Clin Dev, Shanghai 200001, Peoples R China
5.Peoples Liberat Army Gen Hosp, Med Ctr 5, Dept Gastrointestinal Oncol, Beijing 100048, Peoples R China
6.BeiGene Beijing Co Ltd, Biostat, Beijing 102206, Peoples R China
7.Zhejiang Univ, Affiliated Hosp 2, Sch Med, Dept Med Oncol, Hangzhou 310009, Peoples R China
8.Zhejiang Univ, Sch Med, Affiliated Hosp 1, Dept Med Oncol, Hangzhou 310003, Zhejiang, Peoples R China
9.Univ Chinese Acad Sci, Canc Hosp, Dept Med Oncol, Hangzhou 310022, Peoples R China
10.Fujian Med Univ, Union Hosp, Dept Med Oncol, Fuzhou 350001, Peoples R China
推荐引用方式
GB/T 7714		 Li, Jian,Xu, Ye,Zang, Aimin,et al. Tislelizumab in previously treated, locally advanced unresectable/metastatic microsatellite instability-high/ mismatch repair-deficient solid tumors[J]. CHINESE JOURNAL OF CANCER RESEARCH,2024,36.
APA Li, Jian.,Xu, Ye.,Zang, Aimin.,Gao, Yunong.,Gao, Quanli.,...&Shen, Lin.(2024).Tislelizumab in previously treated, locally advanced unresectable/metastatic microsatellite instability-high/ mismatch repair-deficient solid tumors.CHINESE JOURNAL OF CANCER RESEARCH,36.
MLA Li, Jian,et al."Tislelizumab in previously treated, locally advanced unresectable/metastatic microsatellite instability-high/ mismatch repair-deficient solid tumors".CHINESE JOURNAL OF CANCER RESEARCH 36(2024).

入库方式： OAI收割

来源：合肥物质科学研究院

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