- In the first phase 3 trial evaluating a PARP inhibitor following platinum-based chemotherapy in newly diagnosed patients with advanced ovarian cancer and BRCA mutations, PFS at three years was 60.4%.
- The median time to progression has not been reached yet, while it was 13.8 months with placebo.
Why this matters
- Most newly diagnosed patients in this setting relapse within 3 years of standard therapy with cytoreductive surgery and platinum-based chemotherapy.
- Completed treatment per protocol at 2 years: olaparib 47.3%, placebo 26.9%.
- Median duration of treatment: olaparib 24.6 months, placebo 13.9 months.
- PFS at three years: olaparib 60.4% (median not reached), placebo 26.9% (median 13.8 months).
- Median time to first subsequent therapy or death: olaparib 51.8 months, placebo 15.1 months (hazard ratio, HR 0.30, 95% CI 0.23-0.41, P
- Health-related quality of life (FACT-O TOI score) showed no clinically meaningful difference between study groups over 24 months, indicating that olaparib did not negatively affect QoL versus placebo.
- Olaparib 300 mg bd (n=260) or placebo (n=131) was administered to patients with FIGO stage III or IV and ECOG performance status 0 or 1, who were in complete or partial response after platinum-based chemotherapy until progression.
- Patients with no evidence of disease after 2 years stopped treatment, those with a partial response could continue treatment.
- The patients had excellent prognostic criteria. Discontinuation rate after two years was high.
- “This trial is a sound basis for this treatment to be moved into first line in the BRCA-mutated population of ovarian cancer patients.” Jonathan A. Ledermann, UCL Cancer Institute, London, GB.
- AstraZeneca and MSD.