Pfizer is stopping Phase III development of axitinib for the treatment of advanced pancreatic cancer. The independent Data Safety Monitoring Board (DSMB) during an interim analysis found no evidence of improvement in the primary endpoint of survival in patients treated with axitinib and gemcitabine compared to gemcitabine alone.
“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,” remarks Mace L. Rothenberg, M.D., svp, 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 second-line treatment.”
Axitinib is an oral and selective inhibitor of VEGF receptors 1, 2, and 3. Pfizer notified the various clinical trial investigators involved in the study and regulatory agencies of these interim findings and recommends patients discontinue treatment with axitinib.