- Niraparib was active and well-tolerated in patients with heavily pretreated ovarian cancer, including those with homologous recombination deficiency (HRD)-positive platinum-sensitive disease.
Why this matters
- Treatment of recurrent ovarian cancer remains challenging.
- Multicenter, phase 2 QUADRA study.
- 463 platinum-resistant or platinum-refractory patients with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Primary endpoint: efficacy in platinum-sensitive patients with HRD-positive (BRCA-positive or wild-type) tumors who had received 3-4 previous lines of anticancer therapy (n=47).
- Funding: Tesaro.
- Patients had received a median of 4 previous lines of therapy; the median follow-up for OS, 12.2 months.
- 33% of patients were resistant and 35% were refractory to the last administered platinum therapy.
- Overall response rate (ORR) in primary efficacy population was 28% (P1-sided =.00053).
- median PFS was 5.5 months (95% CI, 3.5-8.2).
- median duration of response was 9.2 months (95% CI, 5.9-not estimable).
- ORR in modified per-protocol population (n=456) was 8%; median OS was 17.2 (95% CI, 14.9-19.8) months.
- The most common drug-related grade ≥3 treatment-emergent adverse events were anemia (24%) and thrombocytopenia (21%).
- 1 treatment-related death occurred.
- Open-label, single-arm study.