Pfizer's Inlyta has failed to hit the key target of a Phase III trial pitting its performance against Bayer/Onyx Pharmaceuticals' rival Nexavar in patients with kidney cancer.
Top-line data from the AGILE 1051 study show that Inlyta (axitinib) "narrowly missed" its primary endpoint in significantly improving progression-free survival (PFS) in treatment-naïve patients with advanced renal cell carcinoma compared to Nexavar (sorafenib).
While the data showed that overall median PFS for Pfizer's drug did indeed exceed that for Nexavar, the difference was not statistically significant, the firm noted.
Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit, said the findings are now being analysed “to determine whether further evaluation of Inlyta in specific subpopulations of treatment-naïve patients with advanced RCC would be warranted.”
A fuller set of data is to be presented at an upcoming medical congress, Pfizer said.
Inlyta is already on the market as a second-line treatment for advanced kidney cancer, having won regulatory approvals in the US, EU, Japan, Switzerland, Canada, Korea, and Australia, but does not hold a license for use as a first-line therapy.
Approval was based, in part, on the Phase III AXIS trial, in which Inlyta significantly extended PFS compared to Nexavar, with a median result of 6.7 months versus 4.7 months, respectively.