- Adding bevacizumab to niraparib extends PFS in patients with high-grade platinum-sensitive recurrent ovarian cancer, irrespective of homologous recombination deficiency (HRD) status or chemotherapy-free interval (CFI).
Why this matters
- Use of standard platinum-based chemotherapy is limited by cumulative toxicity.
- A planned phase 3 trial will compare niraparib+bevacizumab with standard treatment.
- Multinational, phase 2 AVANOVA2/ENGOT-ov24 study of 97 patients with high-grade platinum-sensitive recurrent ovarian cancer randomly assigned to niraparib±bevacizumab.
- Primary endpoint: PFS in the intention-to-treat population; aHRsuperiority, 0.57 after events in 62 patients.
- Funding: Nordic Society of Gynaecological Oncology; Tesaro.
- Median follow-up was 16.9 months.
- Niraparib+bevacizumab significantly improved median PFS vs niraparib monotherapy in:
- Intent-to-treat population (11.9 vs 5.5 months; aHR, 0.35; P<.0001>
- HRD-positive (HR, 0.38; 95% CI, 0.20-0.72) and HRD-negative patients (HR, 0.40; 95% CI, 0.19-0.85).
- Patients with CFI 6-12 months (HR, 0.29; 95% CI, 0.14-0.62) and ≥12 months (HR, 0.42; 95% CI, 0.22-0.80).
- Open-label design.