Positive Phase III data for Zytiga (J&J Janssen Cilag) plus prednisone for Prostate Cancer

Analysis of the Phase III study, COU-AA-302, demonstrated that patients with metastatic castration-resistant Prostate Cancer (mCRPC) treated with Zytiga (abiraterone acetate), from J&J Janssen Cilag, plus prednisone, showed a statistically significant improvement in radiographic progression-free survival (rPFS) and all secondary endpoints compared to patients treated with placebo plus prednisone. The median rPFS in the control arm was 8.3 months but had not yet been reached in the Zytiga arm because progression events were occurring more slowly compared to the control arm. Additionally, treatment with Zytiga plus prednisone resulted in an estimated 33 percent improvement in survival (median overall survival in the Zytiga arm was not reached and was 27.2 months in the control arm). Based on these results, Janssen plans to submit marketing applications with regulatory authorities to extend the use of Zytiga in men with mCRPC who have not received chemotherapy, beginning in the second half of 2012. Results are presented by Johann S. de Bono, The Institute for Cancer Research, The Royal Marsden NHS Foundation Trust, at the Meeting of the American Society of Clinical Oncology.