Results from a pre-specified analysis examining rPFS demonstrated a statistically significant improvement in rPFS in the ZYTIGA plus prednisone arm (ZYTIGA arm) compared to the placebo plus prednisone (control) arm. The median rPFS in the control arm was 8.28 months but had not yet been reached in the ZYTIGA arm because progression events were occurring more slowly in the ZYTIGA arm compared to the control arm (N=150 vs. 251, respectively). These results reached statistical significance with a p-value <0.0001 and a hazard ratio (HR) of 0.425 [95% confidence interval (CI): 0.347, 0.522].Additionally, in a separate pre-specified interim analysis, OS was longer for the ZYTIGA arm compared to the control arm with an HR of 0.792: median overall survival was 35.3 months in the ZYTIGA arm versus 30.1 months in the control arm (95% CI: 0.655 - 0.956). The p-value was 0.0151, which did not meet the pre-specified value for statistical significance.
U.S. FDA Approves Expanded ZYTIGA® Indication For Treatment Of Metastatic Castration-Resistant Prostate Cancer
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