Table 3.
Study | Phase | Population | Study Arm | Control Arm | Results |
---|---|---|---|---|---|
SOLO-1 NCT01844986 |
III | HGSOC/endometrioid (or FP/PPC) FIGO III–IV BRCAm CR/PR platinum-based chemotherapy |
Olaparib 300 mg BID | Placebo | PFS NR vs. 13.8 m HR 0.30 (95% CI 0.23–0.41) |
PRIMA NCT02655016 |
III | HGSOC/endometrioid (or FP/PPC) FIGO III–IV Regardless of BRCA status CR/PR platinum-based chemotherapy |
Niraparib 300 mg daily | Placebo | ITT PFS 13.8 vs. 8.2 m HR 0.62 (95% CI 0.50–0.76) HRD PFS 21.9 vs. 10.4 m HR 0.43 (95% CI 0.31–0.59) BRCAmut 0.40 (95% CI, 0.27–0.62) |
PAOLA-1 NCT02477644 |
III | HGSOC/endometrioid/other epithelial non-mucinous (or FP/PPC) FIGO IIIB, IIIC or IV gBRCAm/BRCAwt if HGS CR/PR platinum-based chemotherapy |
Olaparib 300 mg BID + bevacizumab 15 mg/kg/3 wks | Placebo + Bevacizumab 15 mg/kg/3 wks | ITT PFS 22.1 vs. 16.6 m HR 0.59 (95% CI 0.49–0.72) BRCAmut HR 0.31 (95% CI 0.20–0.47) |
VELIA NCT02470585 |
III | HGSOC OC (or FP/PPC) FIGO III–IV |
Paclitaxel-carboplatin-veliparib (150 mg BID-2 weeks 400 mg BID) → veliparib | Paclitaxel-carboplatin-placebo → placebo | ITT PFS: 23.5 vs. 17.3 m HR 0.68 (95% CI 0.56–0.83) BRCAmut PFS: 34.7 vs. 22 m HR 0.44 (95% CI 0.28–0.68) |