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
作者机构：State Key Laboratory of Oncology in South China&Collaborative Innovation Center of Cancer MedicineGuangdong Provincial Clinical Research Center for CancerSun Yat-sen University Cancer CenterGuangzhouChina Department of Medical OncologySun Yat-sen University Cancer CenterGuangzhouChina Department of Radiation OncologySun Yat-sen Memorial HospitalSun Yat-sen UniversityGuangzhouChina Department of HematologySun Yat-sen University Cancer CenterGuangzhouChina Cancer CenterUnion Hospital affiliated to Tongji Medical College of Huazhong University of Science and TechnologyWuhanChina Department of HematologyThe First Affiliated Hospital of Nanjing Medical UniversityJiangsu Province HospitalNanjingChina Department of HematologyNanfang HospitalSouthern Medical UniversityGuangzhouChina Department of LymphomaGuangdong Provincial People’s HospitalGuangdong Academy of Medical SciencesGuangzhouChina Department of pathologyGuangdong General HospitalGuangdong Academy of Medical SciencesGuangzhouChina Department of Medical OncologyHubei Cancer CenterWuhanChina Department of Clinical ResearchSun Yat-sen University Cancer CenterGuanzhouChina Department of PathologySun Yat-sen University Cancer CenterGuangzhouChina
出 版 物：《Signal Transduction and Targeted Therapy》 (信号转导与靶向治疗（英文）)
年 卷 期：2024年第9卷第6期
页 面：2765-2773页
核心收录：
学科分类：0710[理学-生物学] 1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学]
基 金：supported by the National Natural Science Foundation of China(grant numbers 82170188 and 81970176) Guangdong Basic and Applied Basic Research Foundation(grant number 2021A1515110012)
摘 要：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 *** phase 1b/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 *** 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 *** dose-limiting events were observed,RP2D of chidamide was 30 mg twice a ***-nine patients were enrolled in phase *** 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,*** 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%)*** biomarker assessment suggested that a combination of dynamic plasma ctDNA and EBV-DNA played a vital prognostic ***3 mutation shows an unfavorable *** 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 *** is a promising therapeutic option for this population.
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