SOLO-1 — Olaparib Maintenance Monotherapy in Patients With BRCA-Mutated Advanced Ovarian Cancer Following First-Line Platinum-Based Chemotherapy

Phase 3 · 2018 · Ovarian Cancer

Design

Randomized, double-blind trial of maintenance olaparib versus placebo in patients in response after first-line platinum-based chemotherapy.

Population

Newly diagnosed FIGO III-IV BRCA1/2-mutated high-grade serous or endometrioid ovarian cancer in complete or partial response to platinum.

Primary Endpoint

progression-free survival (PFS)

Key Result

7-year analysis: OS 67% vs 46.5% (HR 0.55); mature median PFS 56.0 vs 13.8 mo (HR 0.30).

Guideline Impact

NCCN category 1 for first-line maintenance in BRCA-mutated advanced ovarian cancer