Stephen Freedland, MD, highlights OS data from EMBARK

Data from the phase 3 EMBARK trial (NCT02319837) showed that the combination of enzalutamide (Xtandi) plus leuprolide significantly improved overall survival (OS) compared with leuprolide alone in patients with high-risk biochemically recurrent prostate cancer.¹

These findings, presented at the 2025 European Society for Medical Oncology Congress in Berlin, Germany, reinforce previous data from EMBARK, which showed that enzalutamide (Xtandi) plus leuprolide and enzalutamide alone significantly improved metastasis-free survival vs leuprolide alone in this patient population. These data led to the FDA approval of enzalutamide in patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis in November 2023.

In an interview with Urology Times®, presenting author Stephen J. Freedland, MD, offered insights into these results. Freedland is a professor of urology at Cedars-Sinai Medical Center in Los Angeles, California.

Specifically, data showed that the combination of enzalutamide plus leuprolide reduced the risk of death by 40.3% vs leuprolide alone (HR, 0.597; 95% CI, 0.444 to 0.804; P = .0006). Further, enzalutamide monotherapy was shown to reduce the risk of death by 17% vs leuprolide alone, although this difference did not reach statistical significance (HR, 0.830; 95% CI, 0.630 to 1.095; P = .1867).

The authors also reported that enzalutamide plus leuprolide and enzalutamide monotherapy extended the time to first use of a new antineoplastic therapy, time to first symptomatic skeletal event, and progression-free survival on first subsequent therapy.

Overall, they concluded, “This unprecedented survival advantage reinforces the MFS results and further supports enza combo as the standard of care for [patients] with [high-risk biochemically recurrent prostate cancer.”

REFERENCE

1. Freedland S, Shore ND, Luz MDA, et al. EMBARK: Overall survival with enzalutamide in biochemically recurrent prostate cancer. Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA37