PAOLA-1 — Platine, Avastin and OLAparib in 1st Line (PAOLA-1/ENGOT-ov25)

Phase 3 · 2019 · Ovarian Cancer

Design

Randomized, double-blind trial of maintenance olaparib plus bevacizumab versus placebo plus bevacizumab after first-line platinum-taxane chemotherapy with bevacizumab.

Population

Newly diagnosed FIGO III-IV high-grade ovarian cancer in response to platinum-based chemotherapy plus bevacizumab, regardless of BRCA status.

Primary Endpoint

progression-free survival (PFS)

Key Result

Final OS (median 61.7 mo): ITT OS 56.5 vs 51.6 mo (HR 0.92, not significant); HRD-positive OS HR 0.62 with PFS 37.2 vs 17.7 mo (HR 0.33).

Guideline Impact

NCCN-recommended first-line maintenance for HRD-positive advanced ovarian cancer