US biopharmaceutical company Pfizer Inc (NYSE:PFE) and Japanese pharmaceutical company Astellas Pharma Inc (TSE:4503) on Thursday announced positive overall survival results from the Phase 3 EMBARK study evaluating XTANDI (enzalutamide), in combination with leuprolide, in men with non-metastatic hormone-sensitive prostate cancer and high-risk biochemical recurrence.

The study met a key secondary endpoint, showing a statistically significant and clinically meaningful overall survival benefit for XTANDI plus leuprolide versus placebo plus leuprolide. XTANDI monotherapy also showed a favourable trend toward improved survival, though it did not reach statistical significance.

No new safety concerns were observed, and the safety profile was consistent with previous data. Common adverse events included hot flashes and fatigue in the combination and placebo groups, and gynecomastia in the monotherapy group.

XTANDI is the first androgen receptor inhibitor-based regimen to show overall survival benefit in this patient population, reinforcing its role in advanced prostate cancer treatment. The therapy is approved in over 80 countries worldwide.