ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced that a first line Phase III study of ERBITUX(R) (Cetuximab) combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
According to the American Cancer Society, 81,550 Americans will be diagnosed with head and neck cancer in 2007, including cancers of the tongue, the rest of the mouth, the salivary glands and inside the throat, the voice box, eye and orbit, thyroid and the lymph nodes in the upper neck.
In addition, it is estimated that more than 12,900 Americans will die from this disease this year. Head and neck cancer most often affects people over the age of 50, and men are twice as likely to be diagnosed as women. The most common risk factors are tobacco and excessive alcohol use.
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). 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.
In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. While the mechanism of ERBITUX’ anti-tumor effect(s) in vivo is unknown, all of these processes may contribute to the overall therapeutic effect of ERBITUX. 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 (Cetuximab), in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. ERBITUX as a single agent 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.
The randomized, multi-center study, known as EXTREME, studied more than 400 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, M.D., 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.”