Overall survival with testosterone suppression plus enzalutamide or standard antiandrogen therapy for metastatic hormone-sensitive prostate cancer

The phase 3 ENZAMET trial, at 83 sites in six countries, randomized patients with metastatic hormone-sensitive prostate cancer (mHSPC) 1:1 to testosterone suppression plus enzalutamide versus testosterone suppression plus standard antiandrogen therapy (bicalutamide, nilutamide, or flutamide; control group). After a median follow-up of 68 months (IQR 67-69), the median overall survival was not reached, with five-year OS rate of 57% in the control group versus 67% in the enzalutamide group (HR 0.70; p<0.0001). OS benefits with enzalutamide were consistent across predefined prognostic subgroups and planned use of concurrent docetaxel. Enzalutamide was tolerated. The authors conclude that addition of enzalutamide to standard of care should be considered as a treatment option for eligible mHSPC patients.