Overview

• More than 1,000 men with high-risk biochemical recurrence after surgery or radiation were randomized to leuprolide, enzalutamide, or the combination across 244 sites in 17 countries.
• At eight years, overall survival was 78.9% with enzalutamide plus leuprolide versus 69.5% with leuprolide alone (HR 0.597; 95% CI 0.444–0.804; P = 0.0006), reflecting a 40.3% lower risk of death.
• Enzalutamide monotherapy was not superior to leuprolide alone for overall survival, according to the New England Journal of Medicine report.
• Secondary outcomes favored the combination, including longer time to first new antineoplastic therapy, fewer symptomatic skeletal events, and improved PFS2, with no new safety signals reported.
• The results were published in NEJM and presented at the ESMO Congress in Berlin, and investigators said the data are likely to strengthen NCCN guidance given enzalutamide’s existing FDA approval.