Phase III study of Zytiga (Janssen) for Prostate Cancer unblinded

A Phase III study of Zytiga (abiraterone acetate), from Janssen, plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant Prostate Cancer (CRPC) has been unblinded. Study COU-AA-302 is an international, placebo controlled study that included 1,088 patients randomised to receive Zytiga (1,000 milligrams) once daily plus prednisone 5 mg twice daily or placebo plus prednisone 5 mg twice daily. The Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding the study based on a planned interim analysis in which differences in radiographic progression-free survival, overall survival, and secondary endpoints were observed that constitute evidence of clinical benefit as well as continued evidence of favorable safety in patients receiving abiraterone acetate plus prednisone as compared to those receiving placebo plus prednisone. Based on these results, the IDMC also recommended that patients in the placebo arm be offered treatment with Zytiga. These results will be presented at an upcoming medical meeting and will also be submitted for publication.