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Joyce F. Liu, MD, MPH
Joyce F. Liu, MD, MPH
Posted: Tuesday, November 11, 2025
The addition of the antiangiogenic agent apatinib to fuzuloparib in the first-line maintenance setting did not lead to an increase in progression-free survival among patients with advanced ovarian cancer who were homologous recombination–deficient. However, in patients who were homologous recombination–proficient, the combination did show a trend toward progression-free survival benefit compared with fuzuloparib alone. Ning Li, PhD, of the Beijing Institute of Technology presented findings from the final analysis of the FZOCUS-1 trial at the European Society for Medical Oncology (ESMO) Congress 2025 (Abstract 1063O).
The randomized, double-blind, placebo-controlled phase III FZOCUS-1 trial was conducted to determine the efficacy of the novel PARP inhibitor fuzuloparib with or without VEGFR-2 inhibitor apatinib as a first-line maintenance therapy for patients with ovarian cancer to understand how the combination performed in comparison with PARP monotherapy.
Patients with newly diagnosed ovarian cancer following a response to first-line platinum-based chemotherapy were enrolled in the study and randomly assigned 2:2:1 to receive fuzuloparib monotherapy at 150 mg twice daily, fuzuloparib at 100 mg twice daily plus apatinib at 375 once daily, or matching placebo as maintenance therapy. The primary endpoint was progression-free survival for the monotherapy vs combination regimen vs placebo in the overall population as well as in patients with germline BRCA1/2 mutations.
Both the monotherapy and combination arms induced prolonged progression-free survival as compared with placebo, whether patients had a germline BRCA mutation or not. In the overall population, the median progression-free survival in the combination arm was 26.9 months vs 29.9 months in the monotherapy arm and 11.1 months in the placebo arm.
In the germline BRCA1/2 mutation subgroup, the median progression-free survival in the combination arm was 45.1 months vs 47.8 months with fuzuloparib monotherapy (hazard ratio [HR] = 0.50; 95% confidence interval [CI] = 0.30–0.84), and the median progression-free survival with placebo was 16.6 months (HR = 0.51; 95% CI = 0.30–0.86).
In the homologous recombination–deficient population, which included patients with BRCA mutations, the median progression-free survival in the combination arm was 34.1 months vs 35.8 months with monotherapy and 16.6 months with placebo. The homologous recombination–proficient population experienced a median progression-free survival of 16.6 months in the combination arm, 11.0 months in the monotherapy arm, and 5.5 months in the placebo arm.
Grade 3 or higher treatment-related adverse events were mostly hematologic and were reported in 48.7% of patients in the combination arm, in 45.7% of patients in the monotherapy arm, and in 7.4% of patients in the placebo arm.
Disclosure: Funding for the study was provided by Jiangsu Hengrui Pharmaceuticals Co., Ltd. Co-author Xinfeng Yang reported a relationship with Jiangsu Hengrui Pharmaceuticals Co., Ltd. All other authors have declared no conflicts of interest.
