Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from PAOLA-1/ENGOT-ov25

The multinational phase 3 PAOLA-1/ENGOT-ov25 trial randomized patients with newly diagnosed stage III or IV ovarian cancer and complete or partial response to first-line platinum-based chemotherapy to two years maintenance treatment with olaparib plus bevacizumab or placebo plus bevacizumab. In the ITT population, median overall survival was 56.5 months in the olaparib-bevacizumab group versus 51.6 months in the placebo-bevacizumab group (HR 0.92; 95% CI0.76-1.12). In the HRD-positive population, OS was longer with olaparib-bevacizumab than with placebo-bevacizumab (HR 0.62; 95% CI 0.45-0.85; 5-year OS rate 65.5% versus 48,4%). Myelodysplastic syndrome, acute myeloid leukemia, aplastic anemia, and new primary malignancy incidence remained low and balanced between arms. The authors conclude that addition of olaparib to first-line bevacizumab maintenance provided OS improvement among patients with HRD-positive ovarian cancer.