Fuzuloparib in combination with apatinib versus fuzuloparib alone for recurrent ovarian cancer: a randomized, open-label, phase 2 trial
Abstract
A randomized, open-label, phase 2 trial assessed fuzuloparib (a PARP inhibitor) plus apatinib (a vascular endothelial growth factor receptor [VEGFR] inhibitor) versus fuzuloparib alone in patients with recurrent ovarian cancer (ROC). Patients with ROC who had failed ≥ 2 lines of platinum-based chemotherapy were enrolled. Patients with primary platinum resistance were also eligible. Patients were randomized 1:1 to receive fuzuloparib plus apatinib or fuzuloparib. The primary endpoint was objective response rate (ORR). As of Jan 11, 2024, 76 eligible patients were enrolled (39 with fuzuloparib plus apatinib and 37 with fuzuloparib). The ORR was 38.5% for fuzuloparib plus apatinib and 35.1% for fuzuloparib alone, with median progression-free survival (PFS) of 7.3 months and 5.5 months, respectively. In patients with platinum resistance, the ORR was 29.6% with fuzuloparib plus apatinib compared to 20.0% with fuzuloparib alone, and the median PFS was 5.6 months versus 3.7 months (HR = 0.63; 95% CI, 0.34 to 1.15; p = 0.1306). In patients without prior VEGFR inhibitor exposure, the ORR was 50.0% with fuzuloparib plus apatinib compared to 36.7% with fuzuloparib alone, and the median PFS was 7.4 months versus 5.5 months (HR = 0.67; 95% CI, 0.38 to 1.19; p = 0.1667). Treatment-related adverse events of grade ≥ 3 occurred in 61.5% and 40.5% of patients in fuzuloparib plus apatinib and fuzuloparib groups. In treating ROC, fuzuloparib plus apatinib didn’t show a significant advantage over fuzuloparib alone. However, in patients with platinum-resistant disease or without prior VEGFR inhibitors exposure, fuzuloparib plus apatinib showed a trend towards benefit. ClinicalTrials.gov, NCT04517357 (Registration Date: August 16, 2020).
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Authors: Guangyi Jiang, Danqing Wang, Wei Wang, Qingshui Li, Jie Tang, Yi Huang, Ruifang An, Wei Duan, Junying Tang, Li Wang, Rong Li, Danbo Wang, Youzhong Zhang, Ge Lou, Bingzhong Zhang, Wen Di, Jiaqin Lin, Yuting Wang, Jianqing Zhu, Rutie Yin
Institutions: Shanghai Jiao Tong University, Sun Yat-sen University, Sichuan University, Chongqing Medical University, Harbin Medical University, Renji Hospital, Sun Yat-sen Memorial Hospital, Shanxi Medical University, Second Hospital of Shanxi Medical University, Zhengzhou University, Beijing Obstetrics and Gynecology Hospital, The Affiliated Yongchuan Hospital of Chongqing Medical University, Hubei Cancer Hospital, Shandong First Medical University, Zhejiang Cancer Hospital, Third Affiliated Hospital of Harbin Medical University, Shandong Tumor Hospital, Henan Cancer Hospital, Jiangsu Hengrui Medicine (China), Qilu Hospital of Shandong University, Hunan Cancer Hospital, Chongqing Cancer Hospital, Liaoning Cancer Hospital & Institute, First Affiliated Hospital of Xi'an Jiaotong University, Shenyang Fifth People Hospital