PRIMA (PRIMA/ ENGO - OV26/ GOG-3012) |
Stage III/IV; high grade serous or endometrioid; CR or PR after 6–9 cycles of chemotherapy; must have had residual disease or were inoperable |
Niraparib maintenance |
Placebo |
|
Progression-free survival in patients with HRD tumors |
HRD positive: 21.9 vs 10.4 months (HR 0.43, 95% CI 0.31–0.59, p < 0.001) favoring niraparib maintenance; Entire cohort: 13.8 vs 8.2 months (HR 0.62, 95% CI 0.50–0.76, p < 0.001) favoring niraparib maintenance |
[1] |
PAOLA-1 (PAOLA-1/ ENGOT-ov25) |
Stage III/IV high grade serous or endometrioid; must have undergone tumor debulking (primary or interval), allowed complete resection; must have received at least 3 cycles of bevacizumab as part of treatment; must have had CR or PR to chemotherapy |
Olaparib + bevaciz umab mainte nance |
Placebo + bevaciz umab mainte nance |
|
Progression-free survival |
22.1 vs 16.6 months (HR 0.59, 95% CI 0.49–0.72, p < 0.001) favoring olaparib maintenance |
[2] |
VELIA (VELIA / GOG-3005) |
Stage III/IV high grade serous; primary or interval tumor debulking with either complete resection or residual disease present; did not need to have a response to chemotherapy |
Carboplatin, paclitaxel, veliparib + veliparib maintenance |
Carboplatin, paclitaxel, veliparib + placebo maintenance |
Carboplatin, paclita xel, placebo + placebo maintenance |
Progression-free survival for patients who received veliparib (treatment and maintenanc e) vs. those that received placebo (treatment and maintenance) |
Women with BRCA mutation: 34.7 vs. 22.0 months (HR 0.44, 95% CI 0.28–0.68, p < 0.001); Women with HRD tumors: 31.9 vs 20.5 months (HR 0.57, 95% CI 0.43–0.76, p < 0.001); intention to treat group: 23.5 vs 17.3 months (HR 0.68, 95% CI 0.56–0.83, p < 0.001) favoring the veliparib arm |
[3] |