Enzalutamide monotherapy was not superior to leuprolide alone
By Lori Solomon HealthDay Reporter
THURSDAY, Oct. 23, 2025 (HealthDay News) — The combination of enzalutamide and leuprolide significantly improves overall survival among patients with prostate cancer and a high risk for biochemical recurrence, according to a study published online Oct. 19 in the New England Journal of Medicine to coincide with the annual meeting of the European Society for Medical Oncology, held from Oct. 17 to 21 in Berlin.
Neal D. Shore, M.D., from START Carolinas in Myrtle Beach, South Carolina, and colleagues conducted a final analysis of the phase 3 EMBARK trial in which patients with prostate cancer and high-risk biochemical recurrence were randomly assigned (1:1:1 ratio) to receive enzalutamide plus leuprolide, leuprolide alone, or enzalutamide monotherapy.
The researchers found that eight-year overall survival was 78.9 percent in the combination group and 69.5 percent in the leuprolide-alone group (hazard ratio for death was 0.60; 95 percent confidence interval, 0.44 to 0.80; P < 0.001). With enzalutamide monotherapy, eight-year overall survival was 73.1 percent, which did not differ significantly from leuprolide alone (hazard ratio, 0.83; 95 percent confidence interval, 0.63 to 1.10; P = 0.19). When compared with the primary analysis of metastasis-free survival, safety findings were consistent.
“After initial treatment, some patients see their prostate cancer come back in an aggressive way and are at risk for their disease to spread quickly,” co-principal investigator Stephen Freedland, M.D., from Cedars-Sinai Cancer in Los Angeles, said in a statement. “Hormone therapy, which is what we’ve been offering patients for 30 years, has not improved survival and neither has anything else. That makes these findings a real game changer.”
Several authors disclosed ties to the pharmaceutical industry, including Pfizer and Astellas Pharma, which supported the study.
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