Inlyta fails Phase III trial as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy .- Pfizer

-Pfizer Inc. has announced that the independent Data Monitoring Committee for the Phase III ATLAS trial evaluating Inlyta (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy recommended stopping the trial at a planned interim analysis due to futility. The recommendation was based on the study failing to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS) for patients treated with Inlyta compared with patients treated with placebo. No new safety signals were observed, and the safety profile was consistent with the known profile of Inlyta in advanced RCC.

ATLAS (A Randomized Double-Blind Phase III Study of Adjuvant Axitinib Versus Placebo in Subjects at High Risk of Recurrent RCC)(NCT01599754) is a global, multicenter, randomized double-blind Phase III trial that investigated the clinical efficacy and safety of adjuvant Inlyta (5 mg twice daily) versus placebo in patients (n=724) at high risk of recurrent RCC following nephrectomy. Patients were dosed up to 3 years (for a minimum of 1 year) in the study and the primary endpoint was disease-free survival (DFS). The study was conducted in collaboration with SFJ Pharmaceuticals, who provided the funding and clinical development supervision to generate the clinical data.