Phase III PRIMA trial of Zejula meets primary endpoint in ovarian cancer

GlaxoSmithKline announced positive results from PRIMA (ENGOT-OV26/GOG-3012), the Phase III randomized, double-blind, placebo-controlled, study of Zejula (niraparib) as a maintenance therapy in patients with first-line ovarian cancer following platinum-based chemotherapy. The study met its primary endpoint of a statistically significant improvement in progression free survival for women regardless of their biomarker status. The safety and tolerability profile of niraparib was consistent with previous clinical trials. The full results from PRIMA will be presented at an upcoming scientific meeting.

The ongoing development program for niraparib includes the Phase III PRIMA trial, a Phase III trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial), and a registrational Phase II treatment trial in patients with ovarian cancer (the QUADRA trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab in metastatic, triple-negative breast cancer and advanced, platinum-resistant ovarian cancer (the TOPACIO trial) and niraparib plus bevacizumab in recurrent, platinum-sensitive ovarian cancer (the ENGOT-OV24/AVANOVA trial).