- Final results show that maintenance therapy with olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, extends overall survival (OS) by nearly 13 months in women with platinum-sensitive relapsed ovarian cancer with a BRCA mutation.
Why this matters
- This is the first randomized phase 3 trial to report on OS with maintenance PARP inhibitor for ovarian cancer.
- Findings suggest that maintenance olaparib sets a new standard of care.
- SOLO2 final OS results of randomized controlled trial of olaparib (300 mg twice daily; n=196) vs placebo (n=99).
- Funding: AstraZeneca and MSD.
- Median follow-up for both groups was 65 months.
- Olaparib extended median OS by 12.9 months relative to placebo: 51.7 months with olaparib vs 38.8 months with placebo (HR, 0.74; 95% CI, 0.54-1.00).
- At 5 years, 42.1% of olaparib recipients were alive vs 33.2% of placebo recipients.
- No new adverse events (AEs) were detected.
- Most common AEs were nausea, fatigue/asthenia, and anemia.
- AEs resulting in dose interruptions in 50% of olaparib vs 19% of placebo recipients; AEs resulting in dose reductions occurred in 28% of olaparib vs 3% of placebo recipients.
- Konstantin Zakashansky of Mount Sinai West in NYC, who was not part of the study, said that findings represent the “largest improvement in overall survival of any recurrent ovarian cancer patient trial reported to date” and that these new data confirm that olaparib “should be the standard maintenance therapy for patients with BRCA-related relapsed ovarian cancer responding to platinum-based chemotherapy.”