- Olaparib resulted in superior objective response rate (ORR) and PFS vs nonplatinum chemotherapy in heavily pretreated patients with platinum-sensitive ovarian cancer harboring germline BRCA mutation.
Why this matters
- Relapsed ovarian cancer has a poor prognosis.
- Randomized, multinational, phase 3 SOLO3 trial of 223 patients with platinum-sensitive relapsed ovarian cancer and a germline BRCA1/2 mutation, randomly assigned to olaparib (n=151) or nonplatinum chemotherapy (n=72).
- Primary outcome: ORR assessed by blinded independent central review (BICR).
- Funding: AstraZeneca.
- ORR was significantly higher with olaparib vs chemotherapy:
- 72.2% vs 51.4%;
- OR, 2.53 (P=.002).
- In post hoc subgroup analysis, olaparib was linked to significantly improved ORR in patients who had received 2 prior lines of treatment:
- 84.6% vs 61.5%;
- OR, 3.44 (95% CI, 1.42-8.54).
- Olaparib was also linked to significantly improved BICR-assessed PFS:
- Median, 13.4 vs 9.2 months;
- HR, 0.62 (P=.013).
- The most common grade ≥3 adverse events were anemia in the olaparib group and palmar-plantar erythrodysesthesia and neutropenia in the chemotherapy group.
- Serious adverse event rate was 23.6% in the olaparib group vs 18.4% in the chemotherapy group.
- 2.2% of patients in the olaparib and 3.9% in the chemotherapy group developed myelodysplastic syndrome/acute myeloid leukemia.
- Open-label study.