Pfizer recently announced that the independent data monitoring committee for the phase III ATLAS trial, which is evaluating axitinib (Inlyta) 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 having failed to demonstrate a clear improvement in the primary endpoint of extending disease-free survival for patients treated with axitinib compared with patients treated with placebo.
“We are disappointed by the outcome of this study…. We will conduct additional analyses on the data that may provide insight into this result,” said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.
