Fuzuloparib prolongs PFS in patients with recurrent ovarian cancer
Maintenance treatment with fuzuloparib resulted in significantly improved progression-free survival (PFS) in patients with platinum-sensitive recurrent ovarian cancer, according to a study presented at SGO 2021.
This phase III, multicentre, double-blind, placebo-controlled trial evaluated 252 patients with platinum-sensitive recurrent ovarian cancer who had previously received ≥2 platinum-based regimens. Participants were randomized in a 2:1 ratio to receive either oral fuzuloparib 150 mg twice/day (n=167) or matching placebo (n=85) on 4-week cycles. Patients continued treatment until radiological disease progression, intolerable toxicity, or withdrawal of consent. [SGO 2021, abstract 11557]
As of data cut-off on July 1, 2020, patients treated with fuzuloparib achieved a significantly longer PFS compared with placebo, as assessed by BICR* (median 12.9 vs 5.5 months; hazard ratio [HR], 0.25, 95 percent confidence interval [CI], 0.17–0.36; one-sided p<0.0001).
PFS was consistently longer in the fuzuloparib arm vs the placebo arm in investigator assessment (median 12.9 vs 5.4 months; HR, 0.27, 95 percent CI, 0.18–0.39; one-sided p<0.0001).
This improvement in PFS with fuzuloparib vs placebo was also consistent regardless of the presence of germline BRCA1/2 mutations (present: median 12.9 vs 5.2 months; HR, 0.14; absent: median 11.1 vs 5.5 months; HR, 0.46).
The median chemotherapy-free interval was not reached in the fuzuloparib arm and was 11.6 months in the placebo arm (p<0.0001).
Patients in the fuzuloparib arm had a longer duration of treatment than those in the placebo arm (median 34.0 vs 25.8 weeks).
Anaemia (25.1 percent) and decreased platelet (16.8 percent), neutrophil (12.6 percent), and white blood cell counts (10.8 percent) were the most common grade ≥3 adverse events (AEs) reported in the fuzuloparib arm, while no AEs were reported in the placebo arm. The reported AEs were manageable with treatment interruption or dose modification.
One AE event led to death in the fuzuloparib arm, but this was not considered treatment related as per the investigator’s assessment.
“Fuzuloparib as maintenance therapy, as compared with placebo, prolonged the median PFS in patients with platinum-sensitive, recurrent ovarian cancer, which was both statistically significant and clinically meaningful,” the researchers concluded.
“Fuzuloparib showed a manageable safety profile, … [with] no new safety signals observed,” they noted. “[P]atients could benefit from fuzuloparib regardless of germline BRCA1/2 mutation [status],” they said.
*BICR: Blinded-independent central review