Multicenter randomized phase 2 trial of olaparib versus paclitaxel versus olaparib plus cediranib for platinum-resistant ovarian cancer

There is an unmet need for novel treatment options for platinum-resistant ovarian cancer. The randomized phase 2 OCTOVA trial, at 15 centers in the UK, evaluated, olaparib monotherapy (O), olaparib plus cediranib (O + C), or weekly paclitaxel (wP) for ovarian cancer recurring within 12 months of platinum therapy. The primary endpoint was progression-free survival with O versus O + C. The figure shows that the PFS was increased with O + C versus O, while there was no significant difference for O versus wP. At 12 and 18 months there were no differences in overall survival for O versus wP and for O versus O + C, but the study was not powered to detect a difference. The mean treatment-related adverse events were diarrhea (4% grade 3) and hypertension (4% grade 3) with O + C. The authors conclude that OCTOVA demonstrated activity of O + C in women with recurrent disease, offering a non-chemotherapy option.