Pfizer and Astellas have announced encouraging phase 3 data from the EMBARK trial demonstrating that Xtandi (enzalutamide), in combination with leuprolide, significantly improves overall survival in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence. These mature data build on the 2023 FDA approval of Xtandi for nmHSPC and particularly highlight the survival advantage of the combination regimen over placebo plus leuprolide. Monotherapy with Xtandi did not achieve a significant survival benefit. Xtandi continues to gain traction as the first androgen receptor inhibitor to show a survival benefit in this patient population and remains a strong commercial product, as evidenced by a 21.6% revenue growth for Astellas in fiscal year 2024.