The primary endpoint of the AGILE 1051 study was progression-free survival (PFS) while the secondary endpoints of the study included overall survival, response rate and safety.
According to the data, Median PFS for Inlyta surpassed the median PFS for sorafenib but failed to meet statistical significance.
Pfizer Oncology Business Unit clinical development and medical affairs senior vice president Dr. Mace Rothenberg said the primary endpoint of the trial was narrowly missed.
"We are analyzing the study findings to determine whether further evaluation of INLYTA in specific subpopulations of treatment-naïve patients with advanced RCC would be warranted," Dr. Rothenberg added.
"Since approval, INLYTA has established its utility in the second-line setting where it is an important treatment option for many patients with advanced kidney cancer."
The study also analyzed the pre-specified subgroups that included patients with either good Performance Status (ECOG PS 0) or intermediate Performance Status (ECOG PS 1).
The median PFS for Inlyta exceeded the median PFS for sorafenib in ECOG PS 0 pre-specified subgroup patients while no difference between Inlyta and sorafenib was noted in ECOG PS 1 pre-specified subgroup patients.
Adverse events for Inlyta were constant with previous findings in Inlyta patients with advanced RCC treated with a prior systemic therapy.