Data presented at the Society of Gynecologic Oncology 2021 Annual Meeting on Women’s Cancer found a statistically significant benefit with fuzuloparib maintenance therapy compared with placebo for patients with platinum-sensitive, recurrent ovarian cancer.
Implementing fuzuloparib as maintenance therapy for patients with platinum-sensitive, recurrent ovarian cancer prolonged median progression-free survival (PFS) when compared with placebo, according to data from a phase 3 trial (NCT03863860) presented at the Society of Gynecologic Oncology (SGO) 2021 Virtual Annual Meeting on Women’s Cancer.
Patients experienced a benefit from fuzuloparib maintenance therapy regardless of germline BRCA1/2 status, and no further safety signals were observed in the analysis.
“Fuzuloparib as maintenance therapy achieved a statistically significant and clinically meaningful improvement in PFS for patients with platinum-sensitive, relapsed ovarian cancer compared with placebo regardless of BRCA mutation and had a manageable safety profile,” presenting author, Ning Li, MD, of the Cancer Hospital of Chinese Academy of Medical Sciences, explained in her presentation of the data.
The randomized, double-blind study assessed the efficacy and safety of fuzuloparib maintenance therapy for this cohort of patients. The population was randomized 2:1 to receive either 150 mg of fuzuloparib (n = 167) or placebo (n = 85) in 4-week cycles.
Eligible patients for the population had platinum-sensitive, relapsed, high-grade serious ovarian, fallopian tube, primary peritoneal, or endometrioid ovarian carcinoma. More, the patients received 2 or more previous platinum-based regimens and achieved a complete or partial response to their last treatment of that type.
The primary end point of the research was PFS assessed by a blinded independent review committee (BIRC). Key secondary end points included investigator-assessed PFS, chemotherapy-free interval, overall survival, safety, and objective response rate for patients with measurable disease at baseline.
The median PFS assessed by BIRC was 12.9 months (95% CI, 11.1-not reached [NR]) for patients receiving fuzuloparib compared with 5.5 months (95% CI, 3.8-5.6) for patients receiving placebo (HR, 0.25; 95% CI, 0.17-0.36; P < .0001). Regardless of BRCA mutation status, median PFS per BIRC assessment was longer for the fuzuloparib group than with placebo.
More, median investigator-assessed PFS showed similar data, with the fuzuloparib group at 12.9 months (95% CI, 11.1-NR) compared with 5.4 months (95% CI, 3.8-5.6) for the placebo group (HR, 0.27; 95% CI, 0.18-0.39; P < .0001).
“Previous phase 1 and phase 2 studies have revealed that fuzuloparib [at] 150 mg [twice daily] was well tolerated as [the recommended phase 2 dose] showed promising antitumor activity in patients with platinum-sensitive, recurrent ovarian cancer and germline BRCA mutations who had received prior 2 to 4 lines of chemotherapy,” Li said.
Focusing on one of the key secondary end points, the median chemotherapy-free interval was NR for patients in the fuzuloparib group and recorded at 11.6 months (95% CI, 8.8-NR) for the placebo group (HR, 0.30; 95%, 0.18-0.48; P < .0001).
Examining the safety profile of fuzuloparib compared with placebo, 48.5% of patients in the fuzuloparib group experienced grade 3 or higher adverse events (AEs) versus only 10.7% in the placebo group. Serious AEs were recorded in 10.8% and 3.8% of patients in the fuzuloparib and placebo groups, respectively. No treatment-related deaths were reported.
Phase 3 research focusing on fuzuloparib as first-line maintenance therapy to treat patients with newly diagnosed advanced ovarian cancer (NCT04229615) is ongoing, with a primary end point of IRC-assessed PFS.
Li N, Zhang Y, Wang J, et al. Fuzuloparib maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer: A multicenter, randomized, double-blind, placebo-controlled, phase III trial. Presented at: 2021 Society of Gynecologic Oncology Virtual Annual Meeting on Women’s Cancer. Abstract 11557.