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GlaxoSmithKline PLC positive headline results in Phase 3 PRIMA study

GlaxoSmithKline plc (LON/NYSE: GSK) has today announced positive results from PRIMA (ENGOT-OV26/GOG-3012), 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, GlaxoSmithKline PLC, 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®.

About PRIMA

PRIMA is a double-blind, randomized Phase 3 study designed to evaluate niraparib versus placebo in first-line Stage III or IV ovarian cancer patients. The study assesses the efficacy of niraparib as maintenance treatment, as measured by progression free survival. Platinum responsive patients were randomized 2:1 to niraparib or placebo. The trial incorporated an individualized niraparib starting dose of 200 mg once-daily in patients with baseline weight <77kg or platelet count <150K/μL and 300 mg in all other patients.

About Ovarian Cancer

Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years.

About niraparib

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three pivotal trials. The ongoing development program for niraparib includes the Phase 3 PRIMA trial, a Phase 3 trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial), and a registrational Phase 2 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). Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.