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DOI: 10.1055/s-0040-1717197
Phase III PAOLA-1/ENGOT-ov25 trial: Olaparib plus bevacizumab (bev) as maintenance therapy in patients (pts) with newly diagnosed, advanced ovarian cancer (OC) treated with platinum-based chemotherapy (PCh) plus bev
Background PAOLA-1/ENGOT-ov25 (NCT02477644) is the first Phase III trial to evaluate the efficacy and safety of a PARP inhibitor with bev as first-line (1L) maintenance therapy for advanced OC, regardless of BRCA1/2 mutation (BRCAm) status.
Methods PAOLA-1 is a randomized, double-blind, international Phase III trial. Eligible pts had newly diagnosed, FIGO stage III-IV, high-grade serous or endometrioid OC, fallopian tube or primary peritoneal cancer. Pts had received standard PCh plus bev and were in clinical complete or partial response. Pts were randomized (2:1) to olaparib tablets (300 mg bid for up to 24 months [m]) plus bev (15 mg/kg, d1, q3w, for 15 m including when combined with PCh) or placebo (pbo) plus bev, stratified by 1L treatment outcome and tumour BRCAm status. The primary endpoint was investigator-assessed progression-free survival in the intent-to-treat population (PFS; modified RECIST v1.1).
Results The primary endpoint in the intent-to-treat population showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS). The safety and tolerability profiles observed in PAOLA-1 were generally consistent with those known for each medicine.
Summary In patients with advanced primary ovarian cancer, maintenance Olaparib resulted in a statistically significant PFS improvement. This is the first time this was demonstrated regardless of BRCA mutation status.
Publication History
Article published online:
07 October 2020
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