Final OS Data from EMBARK Phase 3 Trial: Enzalutamide With ADT for Men at Risk of BRPC

Data from the phase 3 EMBARK trial, combining enzalutamide with standard hormone therapy, recently published in The New England Journal of Medicine and presented at the 2025 European Society for Medical Oncology (ESMO) Congress, reveal that this combination reduces the risk of death by more than 40% over eight years compared to hormone therapy alone.

The trial enrolled over 1,000 men across 244 medical centers in 17 countries, all exhibiting aggressive recurrence signs without detectable metastases on conventional imaging. Patients were randomized to receive either hormone therapy alone, enzalutamide alone, or the combination. Those receiving both enzalutamide and hormone therapy experienced notably improved overall survival, redefining the treatment landscape for this challenging condition. The results validate and extend previous evidence that led to enzalutamide’s earlier regulatory approvals for other prostate cancer contexts. Experts emphasize that this combination therapy is poised to become the new standard of care, addressing a population at high risk of disease progression and death who had limited options before.

These findings mark a major advance in prostate cancer management, as hormone therapy alone had not previously shown survival benefits in this setting. With enzalutamide’s targeted mechanism blocking androgen receptor signaling, the disease’s driver pathway, the combo therapy offers renewed hope for prolonged survival in biochemically recurrent prostate cancer patients worldwide.

Source.