Cometriq cabozantinib: Additional Phase III data

A second interim OS analysis of 658 metastatic RCC patients who progressed after >=1 VEGF receptor tyrosine kinase inhibitor (TKI) in the open-label, international Phase III METEOR trial showed that once-daily 60 mg oral Cometriq met the secondary endpoint of improving OS vs. once-daily 10 mg oral Afinitor everolimus. Exelixis said the OS endpoint assumed a median of 20 months for Cometriq vs. 15 months for Afinitor. An interim OS analysis at a 2-sided p-value of 0.0019 was planned at the time of the primary analysis for PFS if the trial met the primary PFS endpoint. That analysis showed that Cometriq reduced the risk of death by 33% vs. Afinitor, but the p-value of 0.0019 needed to achieve statistical significance was not reached at that time (HR=0.67, 95% CI: 0.51, 0.9, p=0.005). After consulting with FDA and EMA, a second interim analysis was performed, which Exelixis said crossed the boundary for early declaration of statistical significance. The company previously reported data from METEOR (see BioCentury, July 27, 2015; Oct. 5, 2015 & Jan. 11, 2016). ...