GlaxoSmithKline plc announced positive results from PRIMA, the Phase 3 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.
Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said:
Almost 300,000 women around the world are diagnosed with ovarian cancer every year, yet only about 15% of patients are currently eligible to receive PARP inhibitors as their initial therapy. These exciting data demonstrate that ZEJULA has the potential to significantly benefit even more women with this devastating cancer.
The full results from PRIMA will be presented at an upcoming scientific meeting.
Niraparib is marketed in the United States and Europe under the trade name ZEJULA®.