German drugmaker Merck KGaA and US firms Bristol-Myers Squibb and ImClone say that first-line Phase III study data on Erbitux (cetuximab) combined with platinum-based chemotherapy met the primary endpoint of increasing survival in recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
The randomized European trial, known as EXTREME, studied more than 400 patients with their first-in-class epidermal growth factor receptor monoclonal antibody in combination with either cisplatin plus 5-fluorouracil (5-FU) or carboplatin plus 5-FU compared with patients treated with cisplatin plus 5-FU or carboplatin plus 5-FU alone. Results from this study have been submitted for presentation at the 2007 American Society of Clinical Oncology's annual meeting, to be held in Chicago.
According to the firms, head and neck cancer may occur in the epithelial cells of any tissues or organs in the head and neck region excluding the eyes, brain, ears, thyroid or esophagus. Most head and neck cancers occur in the oral cavity (43%) followed by the pharynx (33%) and the larynx (24%). The estimated incidence of this type of cancer in Europe is around 140,000 annually, with over 65,000 deaths per year. Currently, median survival for patients with recurrent or metastatic disease is only about six months, Merck noted.
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