Independent data monitoring committee recommends withdrawal of phase three clinical trial evaluating Pfizer's Inlyta
12 April 2018 -

The independent data monitoring committee (DMC) has recommended the withdrawal of a phase three clinical trial evaluating United States-based Pfizer's Inlyta (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma after nephrectomy, it was reported yesterday.

The company stated that the committee has asked it to halt the trial, named 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 when treated with Inlyta, in comparison to the data recorded in the placebo arm. Disease-Free Survival is the primary endpoint of the trial.

Pfizer global product development oncology chief development officer, Mace 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 renal cell carcinoma.