Promising results for Xtandi plus leuprolide

US pharma giant Pfizer (NYSE: PFE) and  Japan’s Astellas Pharma (TYO: 4503) today announced positive top-line results from the overall survival (OS) analysis from the Phase III EMBARK study evaluating Xtandi (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis.

For patients treated with Xtandi plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically-significant and clinically-meaningful improvement in OS. Results also showed a favorable trend towards improved OS for patients treated with Xtandi monotherapy versus placebo plus leuprolide, however the difference did not reach statistical significance. No new safety signals were observed in the analysis, and the safety results were consistent with the demonstrated safety profile of Xtandi.