Pfizer Discontinues Global Phase III Trial of Axitinib for Futility in Advanced Pancreatic Cancer

03-Feb-2009 - USA

Pfizer Inc announced the discontinuation of a Phase III study of its investigational agent axitinib for the treatment of advanced pancreatic cancer. Based on an interim analysis, an independent Data Safety Monitoring Board (DSMB) found no evidence of improvement in the primary endpoint of survival in patients treated with axitinib and gemcitabine, compared to gemcitabine alone, the current standard of care for patients with advanced pancreatic cancer.

“These results were disappointing, given the trend towards prolonged survival seen in a Phase II study of axitinib in this extremely difficult-to-treat patient population,” said Mace L. Rothenberg, M.D., senior vice president, clinical development and medical affairs, Pfizer’s Oncology Business Unit. “However, we remain steadfastly committed to continued investigation of axitinib in renal cell carcinoma where it is currently in Phase III for 2nd line treatment.”

The Company has notified all clinical trial investigators involved in the study and regulatory agencies of these interim findings and recommends patients discontinue treatment with axitinib. Pfizer encourages investigators to determine the best course of action for their patients. The full data set from this study is being analyzed and more details will be presented at an upcoming medical meeting.

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