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news.ImClone Systems and Bristol-Myers Squibb have said a phase III study of Erbitux combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival in patients with squamous cell carcinoma of the head and neck.
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The study examined patients treated with Erbitux in combination either with cisplatin plus 5-fluorouracil (5-FU) or carboplatin plus 5-FU, compared to patients treated with cisplatin plus 5-FU or carboplatin plus 5-FU alone.
“We are excited by the results of this study, as it is the first large, randomized clinical trial to examine the impact of Erbitux treatment in combination with platinum-based chemotherapy on overall survival in metastatic head and neck cancer,” said Eric Rowinsky, chief medical officer and senior vice president of ImClone Systems.
“Erbitux has already demonstrated improved survival when combined with radiation in locoregionally advanced head and neck cancer.”
Erbitux is a monoclonal antibody (IgG1 Mab) 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, HER1, c-ErbB-1). 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.