ERBITUX Increases Survival In Phase III Lung Cancer Study

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ImClone Systems, Bristol-Myers Squibb today announced that a Phase III study of ERBITUX (Cetuximab) in combination with platinum-based chemotherapy (vinorelbine plus cisplatin) met its primary endpoint of increasing overall survival compared with chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC).

This large, randomized multi-national study, known as FLEX (First-Line Treatment for Patients with Epidermal growth factor inhibitor (EGFR)-EXpressing Advanced NSCLC) was conducted by Merck KGaA, Darmstadt, Germany and enrolled patients with Stage IIIB or Stage IV NSCLC who had not previously received chemotherapy.

"Based on the FLEX results, ERBITUX is the only member of the class of epidermal growth factor inhibitors to demonstrate survival in the first-line treatment of patients with advanced non-small cell lung cancer. Previous pivotal trials involving other agents targeting EGFR have failed to demonstrate a survival advantage for these patients," stated Eric K. Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems. "These are important results for lung cancer patients and health care professionals treating this devastating disease, since there have been very few treatment advances for lung cancer in recent years."

"Studies have shown that ERBITUX improves overall survival for patients with certain head and neck cancers, and now, with the FLEX data, for patients with advanced non-small cell lung cancer," said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb. "We look forward to sharing these data with the medical community."

Results from this study will be submitted for presentation at an upcoming medical conference.

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Merck KGaA, Darmstadt, Germany, is ImClone Systems' ERBITUX partner outside of North America.

About Lung Cancer

The American Cancer Society estimates that in the U.S., more than 213,000 people will be diagnosed with lung cancer in 2007. Lung cancer is the leading cause of cancer-related death in men and women in the U.S., with 160,000 deaths estimated in 2007. Approximately 80 to 85% of these patients will be diagnosed with non-small cell lung cancer, with the majority being diagnosed with locally advanced or metastatic disease.

About ERBITUX (Cetuximab)

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's 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.

ERBITUX is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) 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. The effectiveness of ERBITUX for the treatment of EGFR-expressing mCRC cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX for the treatment of EGFR-expressing mCRC.

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