Zytiga abiraterone acetate: Interim Phase III data

Johnson & Johnson unblinded the double-blind, international Phase III COU-AA-302 trial at the recommendation of an independent DMC after a planned interim analysis showed that Zytiga plus prednisone showed "evidence of clinical benefit" on the co-primary endpoints of radiographic PFS and OS, as well as secondary endpoints, vs. placebo plus prednisone. Details of the analysis were not disclosed. The DMC also recommended that patients in the placebo arm be offered treatment with Zytiga. The trial enrolled 1,088 chemotherapy-naive patients with asymptomatic or mildly asymptomatic metastatic CRPC to receive once-daily 1,000 mg Zytiga plus prednisone or placebo plus prednisone. ...