Pfizer has discontinued 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 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.
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.
Axitinib is an oral and selective inhibitor of VEGF receptors 1, 2 and 3. Axitinib is an investigational agent and has not yet been approved by the FDA or other global regulatory agencies.
Mace Rothenberg, senior vice president of clinical development and medical affairs for oncology business unit at Pfizer, said: 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. However, we remain steadfastly committed to continued investigation of axitinib in renal cell carcinoma where it is currently in Phase III for second line treatment.