The trial showed that enzalutamide plus leuprolide significantly improved overall survival compared to leuprolide alone in patients with high-risk biochemically recurrent prostate cancer. The combination reduced the risk of death by 40%. Enzalutamide monotherapy did not significantly improve survival compared to leuprolide alone.
Study
|
Phase 3, randomized trial [EMBARK, NCT02319837] |
| Biochemically recurrent, castration-sensitive prostate cancer with high-risk features |
| Enzalutamide+leuprolide (n=355) vs leuprolide alone (n=358) vs enzalutamide monotherapy (n=355)
|
Efficacy
|
8-yr OS: 78.9% vs 69.5% (HR 0.60 [0.44-0.80]) vs 73.1% (HR 0.83 [0.63-1.10])
|
Safety
|
Grade >=3 AEs: 52.4% vs 49.4% vs 57.3% |
| Serious AEs: 40.5% vs 37.6% vs 43.5% |
| Discontinuations due to AEs: 27.5% vs 12.7% vs 20.6%
|
N Engl J Med. Published online October 19, 2025
http://doi.org/10.1056/NEJMoa2510310
Reviewed by Ulas D. Bayraktar, MD on Nov 12, 2025
