2 Clarke Drive
Suite 100
Cranbury, NJ 08512
© 2025 MJH Life Sciences™ and OncLive - Clinical Oncology News, Cancer Expert Insights. All rights reserved.
Stephen Freedland, MD, discusses how findings from the phase 3 EMBARK trial suggest a new standard of care in prostate cancer.
“To me, it is such a strong dataset to argue that this is the standard of care. With the HR for OS of 0.597, over a 40% reduction. To our knowledge is the greatest survival benefit ever seen in a phase 3 prostate cancer trial amongst all patients.”
Stephen Freedland, MD, a professor, a urologic surgeon, and the Warschaw, Robertson, Law Families Chair in Prostate Cancer at Cedars-Sinai; as well as associate director of Education & Training and director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai Cancer Institute, discussed data from the phase 3 EMBARK trial (NCT02319837) evaluating overall survival (OS) with enzalutamide (Xtandi) with or without leuprolide vs leuprolide plus placebo in patients with biochemically recurrent prostate cancer. The trial lasted for 37 weeks and enrolled patients with no metastases on bone scans, CT scans, or MRIs per central read or central imaging negative.
Freedland expressed his enthusiasm over the findings from the trial by specifically highlighting the hazard ratio (HR) for OS. Data from the trial displayed a HR for OS of 0.597 corresponding to a reduction of more than 40% in the risk of death in favor of the combination of enzalutamide and leuprolide. Freedland stressed how these data cannot be taken lightly; due to how little precedent there is for such results in a prostate cancer trial.
Freedland suggested that prostate cancer treatments in biochemically recurrent settings now have a strong case for a new enzalutamide-based standard of care. When evaluating data amongst all patients from a prostate cancer trial, the survival benefit based on HR shown by the combination treatment of enzalutamide and leuprolide was amongst some of the best in recent years for prostate cancer Freedland stated. Considering the promising data from the trial, Freedland argued for more use of enzalutamide whether in combination with leuprolide or as a monotherapy.
Disclosures: Freedland reported having consultant roles with Astellas Pharma Inc., AstraZeneca, Bayer, Eli Lilly, Johnson & Johnson Innovative Medicine (formerly Janssen), Merck, Novartis, Pfizer Inc., Sanofi, Sumitomo Pharma America, Inc. (formerly Myovant Sciences, Inc.), and Tolmar.
Related Content: