ImClone, BMS' Erbitux Not Effective in Pancreatic Cancer Study

ImClone Systems and Bristol-Myers Squibb (BMS) have announced that a Phase III study of Erbitux plus gemcitabine in patients with locally advanced unresectable or metastatic pancreatic cancer did not meet its primary endpoint of improving overall survival.

The open-label, randomized study compared Erbitux (cetuximab) plus gemcitabine with gemcitabine alone in more than 700 patients with pancreatic cancer in the first-line treatment setting. The study was conducted in centers throughout the U.S. and Canada. The primary study endpoint of statistically improving overall survival was not met. The companies said they will engage in joint efforts to fully interpret these results.

"This study was designed to examine the Phase II results we previously observed for Erbitux in patients with pancreatic cancer," Eric Rowinsky, chief medical officer and senior vice president of ImClone, said. "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 with or without gemcitabine, as well as our pipeline agents, to improve the outcome for patients with pancreatic cancer."

"We are anxious to understand these data in greater detail and are committed to exploring the potential benefits that Erbitux may provide to cancer patients," Martin Birkhofer, BMS' vice president of oncology global medical affairs, said.

Erbitux is a monoclonal antibody designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR). Erbitux, in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous-cell carcinoma of the head and neck. As a single agent the drug is indicated for the treatment of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

It is also indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy, and as a single agent for patients who are intolerant to irinotecan-based therapy.