Table 3:
Summary of primary therapy studies at the European Society for Medical Oncology 2019 Meeting
Study | Patient Population | Treatment arms | Primary Outcome | Primary Results | Ref | ||
---|---|---|---|---|---|---|---|
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] |