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Futility forces Pfizer to stop phase 3 trial of Inlyta for recurrent renal cell carcinoma

PBR Staff Writer Published 11 April 2018

The independent data monitoring committee (DMC) has recommended the termination of a phase 3 clinical trial assessing Pfizer's Inlyta (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy due to futility.

Pfizer said that the committee has asked it to stop the trial, dubbed Atlas, at a planned interim analysis after finding it to be futile.

The recommendation had come after the late-stage trial could not show a clear improvement in prolonging the patients’ disease-free survival (DFS) when treated with Inlyta, in comparison to the data recorded in the placebo arm. DFS is the primary endpoint of the trial.

Pfizer said that the phase 3 trial did not show any new safety signals while the safety profile was on par with the known profile of the drug in advanced RCC.

Pfizer global product development oncology chief development officer Mace Rothenberg said: “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. We will conduct additional analyses on the data that may provide insight into this result.”

Pfizer said that it will submit detailed efficacy and safety data from the Atlas trial at a future medical meeting.

Rothenberg noted that Pfizer will continue with studies assessing Inlyta in combination with immune checkpoint inhibitors for the treatment of various advanced stage cancers, including RCC.

Inlyta, which has been approved in the US and the European Union to treat advanced renal cell carcinoma (RCC), is a small molecule tyrosine kinase inhibitor which can selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2 and 3,1a. These receptors are proteins that play a role in tumor growth, vascular angiogenesis and advancing of cancer.

Image: Pfizer World Headquarters in Manhattan, New York pictured in 2016. Photo: courtesy of Coolcaesar/