Abiraterone meets prostate cancer endpoint
Johnson & Johnson (NYSE:JNJ) said it unblinded the Phase III COU-AA-301 trial to treat metastatic castration-resistant prostate cancer (CRPC) after a pre-specified interim analysis showed that abiraterone plus prednisone met the primary endpoint of significantly improving overall survival vs. placebo plus prednisone. The IDMC that recommended the unblinding also said patients in the placebo arm should be offered 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. Abiraterone is an inhibitor of steroidal enzyme 17 alpha-hydroxylase/C17, 20 lyase ( CYP17). Additional data will be presented at the European Society for Medical Oncology meeting in Milan in October. ...