- Following first-line platinum-based chemotherapy, patients with newly diagnosed advanced ovarian cancer had significantly improved progression-free survival (PFS) with the addition of olaparib, as compared to bevacizumab, the current standard of care.
Why this matters
- First phase 3 trial to evaluate efficacy and safety of a PARP inhibitor plus bevacizumab as first-line maintenance therapy in advanced ovarian cancer not restricted by surgical outcome or BRCA mutation status.
- PAOLA-1/ENGOT-ov25 was a double-blind, international phase 3 trial with 806 patients in complete or partial response following platinum-based chemotherapy plus bevacizumab.
- Randomisation (2:1) to olaparib 300 mg twice daily for up to 24 months or placebo plus bevacizumab at 15 mg/kg on day 1 every 3 weeks for 15 months.
- These interim results were based on an analysis of 59% of the data.
- Funding: Arcagy Research, AstraZeneca, MSD, and Hoffmann-La Roche.
- After a median follow-up of 24.0 months (olaparib) and 22.7 months (placebo), PFS was 22.1 months vs 16.6 months (HR 0.59; P
- Superiority of olaparib was more pronounced among patients with BRCA mutations (HR 0.31; 95% CI 0.20-0.47) than without (HR 0.71; 95% CI 0.58-0.88) but statistically significant for both groups.
- PFS with olaparib vs placebo was also superior in patients who were HRD-positive (HR 0.33; 95% CI 0.25-0.45), but not in those with negative or unknown HRD status (HR 0.92; 95% CI 0.72-1.17).
- 20% discontinuation rate for adverse events is the highest reported from all trials of PARP inhibitors (placebo: 6%).