首页|Sintilimab(anti-PD-1 antibody)plus chidamide(histone deacetylase inhibitor)in relapsed or refractory extranodal natural killer T-cell lymphoma(SCENT):a phase Ⅰb/Ⅱ study

Sintilimab(anti-PD-1 antibody)plus chidamide(histone deacetylase inhibitor)in relapsed or refractory extranodal natural killer T-cell lymphoma(SCENT):a phase Ⅰb/Ⅱ study

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Anti-PD-1 antibodies are a favorable treatment for relapsed or refractory extranodal natural killer T cell lymphoma(RR-ENKTL),however,the complete response(CR)rate and the duration of response(DOR)need to be improved.This phase 1 b/2 study investigated the safety and efficacy of sintilimab,a fully human anti-PD-1 antibody,plus chidamide,an oral subtype-selective histone deacetylase inhibitor in 38 patients with RR-ENKTL.Expected objective response rate(ORR)of combination treatment was 80％.Patients received escalating doses of chidamide,administered concomitantly with fixed-dose sintilimab in 21-days cycles up to 12 months.No dose-limiting events were observed,RP2D of chidamide was 30 mg twice a week.Twenty-nine patients were enrolled in phase 2.In the intention-to-treat population(n=37),overall response rate was 59.5％with a complete remission rate of 48.6％.The median DOR,progression-free survival(PFS),and overall survival(OS)were 25.3,23.2,and 32.9 months,respectively.The most common grade 3 or higher treatment-emergent adverse events(AEs)were neutropenia(28.9％)and thrombocytopenia(10.5％),immune-related AEs were reported in 18(47.3％)patients.Exploratory biomarker assessment suggested that a combination of dynamic plasma ctDNA and EBV-DNA played a vital prognostic role.STAT3 mutation shows an unfavorable prognosis.Although outcome of anticipate ORR was not achieved,sintilimab plus chidamide was shown to have a manageable safety profile and yielded encouraging CR rate and DOR in RR-ENKTL for the first time.It is a promising therapeutic option for this population.

Yan Gao、Haixia He、Xueping Li、Liling Zhang、Wei Xu、Ru Feng、Wenyu Li、Yin Xiao、Xinxiu Liu、Yu Chen、Xiaoxiao Wang、Bing Bai、Huijing Wu、Qingqing Cai、Zhiming Li、Jibin Li、Suxia Lin、Yanxia He、Liqin Ping、Cheng Huang、Jiaying Mao、Xiujin Chen、Baitian Zhao、Huiqiang Huang

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State Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine,Guangdong Provincial Clinical Research Center for Cancer,Sun Yat-sen University Cancer Center,Guangzhou,China

Department of Medical Oncology,Sun Yat-sen University Cancer Center,Guangzhou,China

Department of Radiation Oncology,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou,China

Department of Hematology,Sun Yat-sen University Cancer Center,Guangzhou,China

Cancer Center,Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology,Wuhan,China

Department of Hematology,The First Affiliated Hospital of Nanjing Medical University,Jiangsu Province Hospital,Nanjing,China

Department of Hematology,Nanfang Hospital,Southern Medical University,Guangzhou,China

Department of Lymphoma,Guangdong Provincial People's Hospital,Guangdong Academy of Medical Sciences,Guangzhou,China

Department of pathology,Guangdong General Hospital,Guangdong Academy of Medical Sciences,Guangzhou,China

Department of Medical Oncology,Hubei Cancer Center,Wuhan,China

Department of Clinical Research,Sun Yat-sen University Cancer Center,Guanzhou,China

Department of Pathology,Sun Yat-sen University Cancer Center,Guangzhou,China

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National Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaGuangdong Basic and Applied Basic Research Foundation

82170188819701762021A1515110012

2024

10.1038/S41392-024-01825-0

信号转导与靶向治疗(英文)

信号转导与靶向治疗(英文)

CSTPCD
ISSN：
年,卷(期)：2024.9(6)