Abiraterone acetate: Interim Phase III data

Johnson & Johnson unblinded the Phase III COU-AA-301 trial at the recommendation of an independent DMC after a pre-specified interim analysis showed that abiraterone plus prednisone met the primary endpoint of significantly improving OS vs. placebo plus prednisone and had an acceptable safety profile. Additionally, the committee recommended that patients in the placebo arm be offered treatment with abiraterone. The partners have an SPA for the trial, which enrolled 1,195 patients who failed one or two chemotherapy regimens, at least one of which contained docetaxel. Additional data will be presented at the European Society for Medical Oncology meeting in Milan in October. ...