Overall survival with enzalutamide in biochemically recurrent prostate cancer: final analysis of EMBARK

The multinational phase 3 EMBARK trial randomized patients with high-risk biochemically recurrent prostate cancer in a 1:1:1 ratio to enzalutamide plus leuprolide (combination group), leuprolide alone (leuprolide-alone group), or enzalutamide monotherapy (monotherapy group). Overall survival results of the trial have now been published. The 8-year OS rate was 78.9% in the combination group and 69.5% in the leuprolide-alone group (HR 0.60; p<0.001), while the 8-year OS rate with monotherapy was 73.1%, which did not differ significantly from that with leuprolide alone (HR 0.83; p=0.19). The authors conclude that OS was significantly longer with the combination of enzalutamide and leuprolide than with leuprolide alone among patients with prostate cancer with high-risk biochemical recurrence, while enzalutamide monotherapy was not superior to leuprolide alone.