Pfizer Announces Top-line Results From Phase 3 Trial Of INLYTA

Pfizer

announced today that a Phase 3 study of INLYTA (axitinib) did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS), versus sorafenib, in treatment-naïve patients with advanced renal cell carcinoma (RCC). A preliminary review of the data showed that overall the median PFS for INLYTA exceeded the median PFS for sorafenib, but did not meet statistical significance. In a pre-specified subgroup of patients classified as good Performance Status (ECOG PS 0), the median PFS for INLYTA exceeded the median PFS for sorafenib. In another pre-specified subgroup of patients classified as intermediate Performance Status (ECOG PS 1), there was no difference between INLYTA and sorafenib.