Pfizer’s kinase inhibitor Inlyta (axitinib) narrowly missed its primary endpoint in a Phase III trial in treatment-naive advanced renal cell carcinoma (RCC) patients. The Agile study, involving over 280 patients, evaluated Inlyta versus sorafenib, and was powered to demonstrate a 78% improvement in progression-free survival (PFS) benefit. However, the results showed that while overall the median PFS for Inlyta was higher than that for sorafenib, statistical significance wasn’t reached. Only in a prespecified subgroup of patients classified as good Performance Status (ECOG PS 0) did PFS for Inlyta significantly exceed that of sorafenib.
Pfizer says it will analyze the study findings before deciding whether to evaluate Inlyta in specific subpopulations of treatment-naive RCC patients. The drug was approved earlier this year in the U.S., Europe, Japan and other markets, for use in patients with previously treated advanced RCC.
Pfizer is separately carrying out a Phase II study with Inlyta in treatment-naive patients with advanced RCC, and a Phase II study in patients with hepatocellular carcinoma. Under a collaborative agreement with Pfizer, SFJ Pharma is carrying out a Phase III study in Asia evaluating the drug as an adjuvant treatment for patients at high risk of recurrent RCC following nephrectomy.