ImClone and Bristol-Myers Squibb announced that a phase III study of cetuximab(Drug information on cetuximab) (Erbitux) plus gemcitabine(Drug information on gemcitabine) (Gemzar) in patients with locally advanced unresectable or metastatic pancreatic cancer did not meet its primary endpoint of improving overall survival.
Conducted by the Southwest Oncology Group (SWOG), the open-label, randomized study compared cetuximab plus gemcitabine to gemcitabine alone in more than 700 patients with pancreatic cancer in the first-line treatment setting. The study was conducted in centers throughout the United States and Canada. It was completed in a significantly shorter time than projected, providing a timely answer to an important research question. SWOG has informed ImClone and Bristol-Myers Squibb that the primary study endpoint of statistically improving overall survival was not met. The three partiesSWOG, ImClone, and Bristol-Myers Squibbwill engage in joint efforts to fully interpret these results.
"This study was designed to examine the phase II results we previously observed for Eribtux in patients with pancreatic cancer," stated Eric K. Rowinsky, MD, chief medical officer and senior vice president of ImClone. "We still consider pancreatic cancer to be of the utmost priority and we intend to pursue additional evaluations with Erbitux including a pilot study of Erbitux and bevacizumab(Drug information on bevacizumab) with or without gemcitabine, as well as our pipeline agents, to improve the outcome for patients with pancreatic cancer."