Positive results from PRIMA ( ENGOT-OV26/GOG-3012 ) were announced. PRIMA is a phase 3 randomized, double-blind, placebo-controlled, study of Niraparib ( Zejula ) 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.

PRIMA is a double-blind, randomized 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 less than 77kg or platelet count less than 150K/μL and 300 mg in all other patients.

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 ( BRAVO trial ), and a registrational phase 2 treatment trial in patients with ovarian cancer ( 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 ( TOPACIO trial ) and Niraparib plus Bevacizumab in recurrent, Platinum-sensitive ovarian cancer ( ENGOT-OV24/AVANOVA trial ).

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. ( Xagena )

Source: GSK, 2019

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