Maintenance therapy with fuzuloparib improved progression-free survival (PFS) compared with placebo in patients with platinum-sensitive, recurrent ovarian cancer regardless of BRCA1/2 status, results of the phase 3 FZOCUS-2 trial showed.
Fuzuloparib also had a manageable safety profile, researchers reported in the Journal of Clinical Oncology.
The FZOCUS-2 trial (ClinicalTrials.gov Identifier: NCT03863860) enrolled 252 patients at 36 sites in China. Patients had platinum-sensitive, recurrent ovarian cancer previously treated with at least 2 platinum-based regimens.
Patients were randomly assigned to receive fuzuloparib at 150 mg twice daily (n=167) or matching placebo (n=85). Baseline patient characteristics were generally well balanced between the study arms.
The median treatment duration was 34.0 weeks (range, 5.7 to 106.6 weeks) with fuzuloparib and 25.8 weeks (range, 6.0 to 60.3 weeks) with placebo.
The median PFS was 12.9 months with fuzuloparib and 5.5 months with placebo (hazard ratio [HR], 0.25; 95% CI, 0.17-0.36; P <.0001), according to a blinded independent review committee.
The investigator-assessed median PFS was 12.9 months with fuzuloparib and 5.4 months with placebo (HR, 0.27; 95% CI, 0.18-0.39).
Per independent review, fuzuloparib significantly prolonged PFS in patients with germline BRCA1/2 mutations (HR, 0.14; 95% CI, 0.07-0.28) and patients without the mutations (HR, 0.46; 95% CI, 0.29-0.74).
Per investigator assessment, fuzuloparib significantly delayed the time to disease progression (HR, 0.20), time to subsequent chemotherapy (HR, 0.30), and time to symptom deterioration (HR, 0.88).
Among patients treated with fuzuloparib, the most common grade 3 or higher treatment-emergent adverse events (AEs) were anemia (25.1%), decreased platelet count (16.8%), and decreased neutrophil count (12.6%). Most AEs were resolved with appropriate supportive care and dose modifications.
Two patients discontinued fuzuloparib due to AEs, 1 due to gastric cancer and another due to a concurrent decrease in white blood cell count and neutrophil count. There was 1 fatal AE in the fuzuloparib arm (sudden cardiac death), which was considered unrelated to treatment.
Disclosures: This research was supported by Jiangsu Hengrui Pharmaceuticals Co, Ltd. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Li N, Zhang Y, Wang J, et al. Fuzuloparib maintenance therapy in patients with platinum-sensitive, recurrent ovarian carcinoma (FZOCUS-2): A multicenter, randomized, double-blind, placebo-controlled, phase III trial. J Clin Oncol. Published online April 11, 2022. doi:10.1200/JCO.21.01511