Inlyta (Pfizer) not superior to Nexavar in Renal Cell Carcinoma trial - 19-Oct-2012

A Phase III study AGILE 1051, of Inlyta (axitinib) from Pfizer, did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS), versus Nexavar (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) meaning symptomatic but ambulatory, 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) meaning asymptomatic, there was no difference between Inlyta and sorafenib.