Overview
- The phase 3 EMBARK trial in 1,068 imaging‑negative men with high‑risk biochemical recurrence found a 40.3% reduction in risk of death for enzalutamide plus leuprolide versus leuprolide alone.
- After roughly eight years of follow‑up, overall survival was 78.9% with the combination versus 69.5% with leuprolide (HR 0.597; 95% CI 0.444–0.804; P = 0.0006).
- Key secondary outcomes also favored the combination, including longer time to first new antineoplastic therapy, fewer symptomatic skeletal events, and improved PFS2.
- Safety showed no new signals, though serious drug‑related adverse events were higher with the combination (8.5% vs 2.5%) as were grade 3 or higher events (19.3% vs 9.5%).
- Enzalutamide monotherapy was not superior for overall survival; the FDA‑approved drug already appears in NCCN guidance, investigators expect strengthened recommendations, and the trial was sponsored by Astellas and Pfizer.