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ATLAS trial of axitinib for renal cell carcinoma stopped due to futility
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The independent data monitoring committee for the phase 3 ATLAS trial of axitinib recommended stopping the trial at a planned interim analysis due to a lack of clear improvement in the primary endpoint of DFS, according to the agent’s manufacturer.
Researchers of the trial assessed adjuvant axitinib (Inlyta, Pfizer) compared with placebo for patients at high risk for recurrent renal cell carcinoma after nephrectomy.
“We are disappointed by the outcome of this study as we had hoped the efficacy that Inlyta has demonstrated as a second-line treatment [among] 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,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer, said in a press release. “We will conduct additional analyses on the data that may provide insight into this result. Studies evaluating Inlyta in combination with immune checkpoint inhibitors for patients with a variety of advanced-stage cancers, including renal cell carcinoma, will continue.”
Researchers observed no new safety signals with axitinib. The safety profile appeared consistent with previous trials in advanced renal cell carcinoma.
Results from the ATLAS study will be presented at a future medical meeting.