Zytiga abiraterone acetate: Additional Phase III data

Additional data from the double-blind, international Phase III COU-AA-302 trial in 1,088 patients showed that Zytiga plus prednisone led to median OS, a co-primary endpoint, of 35.3 months vs. 30.1 months for placebo plus prednisone (p=0.0151). However, the pre-specified boundary of p=0.0035 for significance on the OS endpoint has not been reached at the observed number of events (about 55%). The trial enrolled chemotherapy-naive patients with asymptomatic or mildly asymptomatic metastatic CRPC to receive once-daily 1,000 mg Zytiga plus prednisone or placebo plus prednisone. Data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in Orlando. Last year, J&J reported that Zytiga plus prednisone met the co-primary endpoint of radiographic PFS vs. placebo plus prednisone (16.5 vs. 8.3 months, p<0.001) (see BioCentury, June 4, 2012; Oct. 15, 2012; & Dec. 17, 2012). ...