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Adding Cetuximab to Platinum-Based Chemotherapy Improves Overall Survival in Head and Neck Cancers

NEW YORK--(BUSINESS WIRE)--ImClone Systems Incorporated (NASDAQ: IMCL - News) and Bristol-Myers Squibb Company (NYSE: BMY - News) today announced the publication of results from a Phase 3 trial in the New England Journal of Medicine of ERBITUX® (cetuximab) plus platinum-based chemotherapy in the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Results of the study, known as EXTREME (ErbituX in first-line Treatment of REcurrent or MEtastatic head & neck cancer) and conducted by Merck KGaA, Darmstadt, Germany, show that adding ERBITUX to a platinum-based chemotherapy in the first-line treatment of SCCHN resulted in statistically significant improvement in the primary endpoint of overall survival, as well as secondary endpoints of progression-free survival and overall response rate.

The open-label, multicenter, randomized study enrolled a total of 442 patients with previously untreated recurrent and/or metastatic SCCHN randomized to receive either ERBITUX along with a platinum-based chemotherapy (cisplatin or carboplatin) plus 5-fluorouracil (5-FU), or chemotherapy alone. Platinum-based chemotherapy is currently the standard treatment for recurrent or metastatic SCCHN. Results show that patients who received ERBITUX plus platinum-based chemotherapy experienced a statistically significant increase in median overall survival of 2.7 months, compared to patients who received chemotherapy alone (10.1 months vs. 7.4 months, respectively) [HR: 0.80; 95% CI: 0.64-0.99; p=0.036]. Patients who received ERBITUX plus platinum-based chemotherapy also experienced a significant increase in median progression-free survival of 2.3 months (5.6 vs. 3.3 months, respectively) [HR: 0.54; 95% CI: 0.43-0.67; p “With the results of EXTREME, ERBITUX is now the first biologic to demonstrate a significant survival improvement for patients with recurrent or metastatic head and neck cancer,” said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President, ImClone. “We are committed to exploring the utility and developing ERBITUX in a much wider range of cancers.”

“These results add to the growing body of ERBITUX data for the treatment of head and neck cancer,” said Maurizio Voi, M.D., Executive Director, Oncology Global Medical Affairs, Bristol-Myers Squibb. “Through our comprehensive research program, we continue to explore and answer important questions for patients and health care professionals about the potential use of ERBITUX to treat a variety of cancers – particularly those with the highest unmet treatment needs.”

In EXTREME, the most common grade 3 or 4 adverse events in the chemotherapy-alone and ERBITUX groups were anemia (19% and 13%, respectively), neutropenia (23% and 22%, respectively), and thrombocytopenia (11% in both groups). Sepsis occurred in nine patients in the ERBITUX group and in one patient in the chemotherapy-alone group (p=0.02). Of 219 patients receiving ERBITUX, nine percent had grade 3 skin reactions (vs. 0% in chemotherapy-alone group; p ERBITUX is currently approved in the United States for use in combination with radiation therapy for the treatment of locally or regionally advanced SCCHN, and as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.

This study is the basis for the recent supplemental biologics license application (sBLA) submitted by ImClone to the U.S. Food and Drug Administration (FDA) on August 29, 2008. These data were previously presented at the American Society of Clinical Oncology (ASCO) meeting in June 2007 and at the European Congress of Clinical Oncology (ECCO) in September 2007.

About Head and Neck Cancer
According to the American Cancer Society, 87,290 Americans will be diagnosed with head and neck cancer in 2008, 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.1 In addition, it is estimated that more than 13,090 Americans will die from this disease this year.2 Head and neck cancer most often affects people over the age of 50, and men are twice as likely to be diagnosed as women.3 The most common risk factors are tobacco and excessive alcohol use.4

About ERBITUX® (Cetuximab)
ERBITUX (cetuximab) 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. In vitro assays and in vivo animal studies have shown that ERBITUX inhibits the growth and survival of tumor cells that express the EGFR. No anti-tumor effects of ERBITUX were observed in human tumor xenografts lacking EGFR expression.

Squamous Cell Carcinoma of the Head and Neck (SCCHN)
ERBITUX, in combination with radiation therapy, is indicated for the initial 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.

Source: ImClone Systems Incorporated and Bristol-Myers Squibb Company

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