Johnson & Johnson (NYSE:JNJ) unblinded the Phase III COU-AA-302 trial in chemotherapy-naive castration-resistant prostate cancer after Zytiga plus prednisone showed "evidence of clinical benefit" on the co-primary endpoints of radiographic progression-free survival (PFS) and overall survival (OS) vs. prednisone alone. J&J based the decision on the recommendation of an independent DMC, which conducted an interim analysis. Details of the analysis were not disclosed. The trial enrolled 1,088 chemotherapy-naive patients with asymptomatic or mildly asymptomatic metastatic CRPC.
Zytiga is approved in the U.S. in combination with prednisone to treat patients with metastatic CRPC who have received prior chemotherapy containing docetaxel. Next half, J&J plans to submit an sNDA to FDA, as well as worldwide regulatory applications, for Zytiga to treat men with metastatic CRPC who have not yet received chemotherapy. J&J gained Zytiga through its 2009 acquisition of Cougar Biotechnology Inc., which received rights to the product from BTG in 2004. BTG was up 15.30 to 365p on Thursday. Zytiga is an inhibitor of steroidal enzyme 17 alpha-hydroxylase/C17, 20 lyase (CYP17).
Zytiga would be a potential competitor to Provenge sipuleucel-T, which is marketed by Dendreon Corp. (NASDAQ:DNDN) for asymptomatic or minimally symptomatic metastatic CRPC. Dendreon fell as much as 17% on Thursday before closing off 7%, or $0.76, to $10.11. Provenge consists of autologous dendritic cells loaded with a fusion protein of prostatic acid phosphatase and an immunostimulatory cytokine
