IMCLONE, BMS ANNOUNCE RESULTS OF ERBITUX STUDY

ImClone Systems and Bristol-Myers Squibb (BMS) have announced that a Phase III study of Erbitux (cetuximab) plus Folfiri (an irinotecan-based chemotherapy) met the primary endpoint of increasing median duration of progression-free survival over Folfiri alone in patients with previously untreated metastatic colorectal cancer. More than 1,000 patients were recruited from around the world to participate in the study, known as the CRYSTAL study.

"This study demonstrates the potential benefit of adding Erbitux to first-line treatment of metastatic colorectal cancer," Eric Rowinsky, chief medical officer and senior vice president of ImClone, said. The study was conducted by Merck KGaA, ImClone's Erbitux partner outside of North America.

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). In vitro assays and in vivo animal studies have shown that binding of Erbitux to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis and decreased matrix metalloproteinase and vascular endothelial growth factor production. While the mechanism of Erbitux's antitumor effect in vivo is unknown, all of these processes may contribute to the overall therapeutic effect of the drug. EGFR is part of a signaling pathway that is linked to the growth and development of many human cancers, including those of the head and neck, colon and rectum.

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 it 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.