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. No new safety signals were observed, and the safety profile was consistent with the known profile of axitinib in advanced RCC.
“We are disappointed by the outcome of this study, as we had hoped the efficacy that axitinib has demonstrated as a second-line treatment in patients with advanced renal cell carcinoma would carry over to patients with earlier-stage disease, where it would delay or prevent disease relapse. That goal was not achieved. We will conduct additional analyses on the data that may provide insight into this result. Studies evaluating axitinib in combination with immune checkpoint inhibitors for patients with a variety of advanced-stage cancers, including RCC, will continue,” said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.
Detailed efficacy and safety data from ATLAS will be submitted for presentation at a future medical meeting.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.