Pd24-09 phase ii, multi-center study of sintilimab in combination with axitinib in patients with advanced fumarate hydratase-deficient renal cell carcinoma

You have accessJournal of UrologyCME1 Apr 2023PD24-09 PHASE II, MULTI-CENTER STUDY OF SINTILIMAB IN COMBINATION WITH AXITINIB IN PATIENTS WITH ADVANCED FUMARATE HYDRATASE-DEFICIENT RENAL CELL CARCINOMA Xingming Zhang, Haoyang Liu, Yaowen Zhang, Junjie Zhao, Yuntian Chen, Yuhao Zeng, Zilin Wang, Guangxi Sun, Jiayu Liang, Sha Zhu, Jinge Zhao, Linmao Zheng, Xiaoxue Yin, Junru Chen, Xu Hu, Xinan Sheng, Yongquan Wang, Kan Gong, Xiaodong Liu, Rui Huang, Qiang Wei, Xiang Li, Jiyan Liu, Pengfei Shen, Ni Chen, Jin Yao, Zhenhua Liu, and Hao Zeng Xingming ZhangXingming Zhang More articles by this author , Haoyang LiuHaoyang Liu More articles by this author , Yaowen ZhangYaowen Zhang More articles by this author , Junjie ZhaoJunjie Zhao More articles by this author , Yuntian ChenYuntian Chen More articles by this author , Yuhao ZengYuhao Zeng More articles by this author , Zilin WangZilin Wang More articles by this author , Guangxi SunGuangxi Sun More articles by this author , Jiayu LiangJiayu Liang More articles by this author , Sha ZhuSha Zhu More articles by this author , Jinge ZhaoJinge Zhao More articles by this author , Linmao ZhengLinmao Zheng More articles by this author , Xiaoxue YinXiaoxue Yin More articles by this author , Junru ChenJunru Chen More articles by this author , Xu HuXu Hu More articles by this author , Xinan ShengXinan Sheng More articles by this author , Yongquan WangYongquan Wang More articles by this author , Kan GongKan Gong More articles by this author , Xiaodong LiuXiaodong Liu More articles by this author , Rui HuangRui Huang More articles by this author , Qiang WeiQiang Wei More articles by this author , Xiang LiXiang Li More articles by this author , Jiyan LiuJiyan Liu More articles by this author , Pengfei ShenPengfei Shen More articles by this author , Ni ChenNi Chen More articles by this author , Jin YaoJin Yao More articles by this author , Zhenhua LiuZhenhua Liu More articles by this author , and Hao ZengHao Zeng More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003302.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Fumarate hydratase-deficient renal cell carcinoma (FH-RCC) is a rare and highly aggressive cancer mainly caused by germline or somatic aberrant of FH gene. Unfortunately, there are no standard treatment. Here we report the preliminary results of a phase II study investigating the efficacy and safety of sintilimab in combination with axitinib in patients with FH-RCC. METHODS: Patients were treated at mutli-center in hospitals of the republic of China. Eligibility criteria included age ≥18 years and newly diagnosed as FH-RCC by FH immunohistochemistry and next-generation sequencing or multiplex ligation-dependent probe amplification. Patients received sintilimab (intravenous injection, every 3 week) in combination with axitinib (5 mg, orally taken per day) as first-line treatment until disease progression or intolerant to treatment. The primary end point was objective response rate (ORR; RECIST v1.1). This study is registered with ClinicalTrials.gov, NCT04387500. RESULTS: Between July 2021 and October 2022, 21 patients were enrolled. At this preliminary analysis (data cutoff, October, 2022), median follow-up was 9 months (0.9-15.2 months). Nineteen patients were available for efficacy assessment. Confirmed complete response rate was 15.8% (3/19), ORR was 63.1% (12/19). Disease-controlled rate (DCR) was 89.4% (17/19). The median of progression-free survival (PFS) was not reached, with a high 12-month PFS rate of 72.3%. All grade and ≥3 treatment-emergent adverse events occurred in 95% (20/21) and 23.8% (5/21), respectively. CONCLUSIONS: Sintilimab in combination with Axitinib had a manageable safety profile and achieved a promising tumor response rate in patients with advanced FH-RCC. The trial is an ongoing study, with a total of planned 41 patients from 8 sites. The study start date was June 2, 2021. Source of Funding: This work was supported by the Natural Science Foundation of China (NSFC 82172785, 82103097, 81902577, 81974398, 81872107 and 81872108), China Postdoctoral Science Foundation (2020M673239, 2021M692286 and 2021M692281), Research Foundation for the Postdoctoral Program of Sichuan University (2021SCU12014 and 2022SCU12042), 1.3.5 project for disciplines of excellence, West China Hospital, Sichuan University (ZYJC21020), and Science and Technology Support Program of Sichuan Province (2021YFS0119), Post-Doctor Research Project, West China Hospital, Sichuan University (20HXBH026, 2021HXBH036 and 2021HXBH028) © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e726 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Xingming Zhang More articles by this author Haoyang Liu More articles by this author Yaowen Zhang More articles by this author Junjie Zhao More articles by this author Yuntian Chen More articles by this author Yuhao Zeng More articles by this author Zilin Wang More articles by this author Guangxi Sun More articles by this author Jiayu Liang More articles by this author Sha Zhu More articles by this author Jinge Zhao More articles by this author Linmao Zheng More articles by this author Xiaoxue Yin More articles by this author Junru Chen More articles by this author Xu Hu More articles by this author Xinan Sheng More articles by this author Yongquan Wang More articles by this author Kan Gong More articles by this author Xiaodong Liu More articles by this author Rui Huang More articles by this author Qiang Wei More articles by this author Xiang Li More articles by this author Jiyan Liu More articles by this author Pengfei Shen More articles by this author Ni Chen More articles by this author Jin Yao More articles by this author Zhenhua Liu More articles by this author Hao Zeng More articles by this author Expand All Advertisement PDF downloadLoading ...