Inlyta Phase 3 Trial Results in Treatment-Naïve Patients with Advanced Renal Cell Carcinoma

Pfizer announced 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. These data will be further analyzed and presented at an upcoming medical congress.

Inlyta is indicated for the treatment of advanced RCC after failure of one prior systemic therapy. Inlyta, a kinase inhibitor, is an oral therapy that is designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3; these receptors can influence tumor growth, vascular angiogenesis and progression of cancer.

For more information visit www.Pfizer.com or call (800) 438-1985.