Enzalutamide monotherapy was not superior to leuprolide alone<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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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<\/em> to coincide with the annual meeting of the European Society for Medical Oncology, held from Oct. 17 to 21 in Berlin.<\/p>\n 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.<\/p>\n 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.<\/p>\n \u201cAfter initial treatment, some patients see their prostate cancer come back in an aggressive way and are at risk for their disease to spread quickly,\u201d co-principal investigator Stephen Freedland, M.D., from Cedars-Sinai Cancer in Los Angeles, said in a statement. \u201cHormone therapy, which is what we\u2019ve been offering patients for 30 years, has not improved survival and neither has anything else. That makes these findings a real game changer.\u201d<\/p>\n Several authors disclosed ties to the pharmaceutical industry, including Pfizer and Astellas Pharma, which supported the study.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n