- In women with BRCA+, platinum-sensitive advanced ovarian cancer, olaparib maintenance therapy lowered the risk for disease progression or death by 70% vs placebo.
Why this matters
- Nearly 70% of patients relapse within 3 years of initial treatment; maintenance olaparib can become standard treatment in this setting.
- Randomized, double-blind, phase 3 SOLO1 study of 391 BRCA1/2-mutated patients with newly diagnosed advanced high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer who received cytoreductive surgery and platinum-based chemotherapy.
- 260 patients were assigned to maintenance olaparib, and 131 to placebo.
- Primary endpoint: PFS (time to disease progression or death).
- Funding: AstraZeneca; MSD.
- Median follow-up was 41 months.
- 3-year PFS rate was significantly higher in patients who received olaparib vs placebo (60% vs 27%; HR, 0.30; P<.001>
- Time to first subsequent therapy or death was significantly longer with olaparib vs placebo (median, 51.8 vs 15.1 months; HR, 0.30; 95% CI, 0.22-0.40).
- 21% of the patients in the olaparib group experienced serious adverse events vs 12% in the placebo group.
- Anemia was the most common serious adverse event with olaparib.
- Health-related QoL did not change significantly in both groups.
- OS data were immature.