Enzalutamide Plus Androgen Deprivation Therapy in Biochemically Recurrent Prostate Cancer
Key Clinical Takeaways
- Design/Population: The phase 3 EMBARK study evaluated enzalutamide + ADT, enzalutamide monotherapy, and ADT alone in men with high-risk, biochemically recurrent prostate cancer with negative conventional imaging. This population has historically lacked clear treatment options despite high metastatic potential.
- Key Outcomes: Previously published data demonstrated significant improvement in metastasis-free survival with enzalutamide plus ADT or enzalutamide alone versus ADT alone. In the final overall survival analysis presented at ESMO 2025, enzalutamide + ADT reduced the risk of death by 17% compared with ADT alone, though the result did not reach statistical significance.
- Clinical Relevance: The findings support the benefit of early treatment intensification with enzalutamide in high-risk biochemical recurrence. The therapy meaningfully delays metastasis and may improve long-term survival, reinforcing its global regulatory approvals and clinical adoption.
Stephen Freedland, MD, Cedars-Sinai Medical Center, Los Angeles, California, discusses final overall survival results from the EMBARK study, which evaluated enzalutamide plus androgen deprivation therapy (ADT), enzalutamide monotherapy, and ADT alone in patients with high-risk biochemical recurrence and negative conventional imaging.
Results demonstrated that enzalutamide plus ADT reduced the risk of death by 17%, although this did not meet statistical significance. These data highlight the clinical value of enzalutamide-based therapy in delaying disease progression and potentially improving outcomes in this high-risk population.
These findings were presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany.
Source:
Freedland S, Shore ND, De Almedia Luz M, et al. Overall survival with enzalutamide in biochemically recurrent prostate cancer. Presented at the 2025 ESMO Congress. October 17-21, 2025; Berlin, Germany. LBA87
