Pfizer is terminating a late-stage trial assessing Inlyta in patients at risk of kidney cancer recurrence after an interim analysis showed that it was highly unlikely the drug would offer any benefit in this setting.
The Phase III ATLAS trial was assessing Inlyta’s (axitinib) potential as an adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy.
However, a futility analysis by an independent Data Monitoring Committee found that the study failed to demonstrate a clear improvement in the primary endpoint of extending disease-free survival for patients treated with Pfizer’s drug compared to those given a placebo.
“We are disappointed by the outcome of this study as we had hoped the efficacy that Inlyta 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,” said Mace Rothenberg, chief development officer, Oncology, Pfizer Global Product Development.
“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 RCC, will continue,” he added.
Inlyta is an oral kinase inhibitor designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which play a role in tumor growth, vascular angiogenesis and progression of cancer.
The drug was approved in Europe to treat advanced RCC in patients who have failed to respond to prior therapy with Pfizer's own Sutent (sunitinib) or a cytokine back in 2012.