By Fineline Cube 
Partners Pfizer (NYSE: PFE) and Astellas Pharma Inc. (TYO: 4503) announced positive topline results from the Phase III EMBARK study, demonstrating a statistically significant improvement in overall survival (OS) for men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) at high risk of metastasis.
Study Design and Enrollment
The EMBARK trial was a randomized, double-blind, placebo-controlled, multinational, multicenter study evaluating Xtandi (enzalutamide) in combination with leuprolide or as a monotherapy. The study enrolled 1,068 patients with nmHSPC and high-risk biochemical recurrence (BCR) across sites in the United States, Canada, Europe, South America, and the Asia-Pacific region.
Key Findings
In the comparison of “Xtandi + leuprolide” versus “placebo + leuprolide,” the trial met its key secondary endpoint, showing a statistically significant and clinically meaningful improvement in OS. While the “Xtandi monotherapy” versus “placebo + leuprolide” comparison also showed a favorable trend, the difference did not reach statistical significance. No new safety signals were identified, and the safety profile was consistent with Xtandi’s well-established tolerability.
Xtandi’s Global Impact
Enzalutamide, an androgen receptor signaling inhibitor, has become a standard of care in clinical practice. It is approved in over 80 countries worldwide for various forms of prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC), and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk BCR. To date, it has benefited over 1.5 million patients globally.-Fineline Info & Tech