Pfizer's Inlyta misses primary endpoint in Ph III kidney cancer trial

US drugs behemoth Pfizer (NYSE: PFE) revealed yesterday that a Phase III study of Inlyta axitinib) did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS), versus sorafenib (Bayer/Onyx's Nexavar), in treatment-naive 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. Adverse events for INLYTA were generally consistent with previous findings in Inlyta patients with advanced RCC who had been treated with a prior systemic therapy. These data will be further analyzed and presented at an upcoming medical congress.

“We narrowly missed the primary endpoint in this trial,” said Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit, adding: “We are analyzing the study findings to determine whether further evaluation of Inlyta specific subpopulations of treatment-naive patients with advanced RCC would be