ImClone Systems Incorporated (NASDAQ: IMCL) announced overall survival results from BMS CA225-099 (BMS-099), an open-label Phase 3 study of ERBITUX® (cetuximab) in combination with a taxane and carboplatin in the first-line treatment of all histological subtypes of advanced non-small cell lung cancer (NSCLC).

These results pertaining to overall survival, a secondary endpoint, are an update to the previously reported results for progression-free survival (PFS), the study's primary endpoint, which were announced in June 2007. The study did not meet its primary endpoint of PFS, as assessed by an independent radiology review committee (IRRC). Response rate, as assessed by the IRRC, and PFS, as assessed by clinical investigators, were statistically significant and favored the ERBITUX-containing arm.

In this recently completed analysis of BMS-099, median overall survival in patients receiving ERBITUX in combination with a taxane and carboplatin was 9.7 months, compared to 8.4 months with chemotherapy alone, with a hazard ratio of 0.89 [95% CI = 0.75-1.05], p=0.17.

The results from this overall survival analysis did not reach statistical significance. BMS-099, a 676-patient study, was not powered to detect an improvement in overall survival with the same degree of statistical precision as was the larger 1,125-patient pivotal FLEX (First-line in Lung cancer with ErbituX) multinational Phase 3 study conducted by Merck KGaA, Darmstadt, Germany. Nonetheless, the BMS-099 survival results support those of FLEX, of which overall survival was the primary endpoint.

As recently reported, results from FLEX, demonstrated a statistically significant improvement in overall survival in patients receiving ERBITUX in combination with vinorelbine and cisplatin when compared to chemotherapy (11.3 months vs 10.1 months) with a hazard ratio of 0.871 [95% CI = 0.762-0.996], p=0.044. ImClone and Bristol-Myers Squibb continue to pursue a regulatory filing with the U.S. Food and Drug Administration for the first-line treatment of patients with advanced NSCLC.

"With less than one in five advanced-stage non-small cell lung cancer patients currently receiving biologic-based combination therapy in the first-line setting, ImClone is committed to providing new treatment options to address this unmet medical need," said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone Systems.

The BMS-099 study, performed in the U.S. and Canada, was one of several clinical trials intended to assess the potential of ERBITUX in the treatment of advanced NSCLC. Full BMS-099 study results, including efficacy and safety, will be submitted to a major medical meeting later this year.

About Lung Cancer

The American Cancer Society estimates that in the United States, more than 215,000 people will be diagnosed with lung cancer in 2008, which accounts for about 15 percent of all cancer diagnoses. Approximately 87 percent of these patients will be diagnosed with NSCLC, with many being diagnosed with locally advanced or metastatic disease. Lung cancer is the leading cause of cancer-related death in men and women, with more than 161,000 deaths expected to occur in 2008 - accounting for about 29 percent of all cancer deaths. In 2008, it is estimated that more Americans will die from lung cancer than breast, prostate, and colorectal cancers combined.

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 (cetuximab), 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.

Colorectal Cancer

ERBITUX, as a single agent, is indicated for the treatment of EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens. ERBITUX, as a single agent, is also indicated for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan-based regimens. ERBITUX, in combination with irinotecan, is indicated for the treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. The effectiveness of ERBITUX in combination with irinotecan is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX in combination with irinotecan for the treatment of EGFR-expressing metastatic colorectal carcinoma.

Important Safety Information

Grade 3/4 infusion reactions occurred in approximately 3% of patients receiving ERBITUX (cetuximab) in clinical trials, with fatal outcome reported in less than 1 in 1000. Serious infusion reactions, requiring medical intervention and immediate, permanent discontinuation of ERBITUX, included rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), hypotension, loss of consciousness, and/or cardiac arrest. Most (90%) of the severe infusion reactions were associated with the first infusion of ERBITUX despite premedication with antihistamines. Caution must be exercised with every ERBITUX infusion, as there were patients who experienced their first severe infusion reaction during later infusions. Monitor patients for 1 hour following ERBITUX infusions in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (eg, epinephrine, corticosteroids, intravenous antihistamines, bronchodilators, and oxygen). Longer observation periods may be required in patients who require treatment for infusion reactions.

Cardiopulmonary arrest and/or sudden death occurred in 4 (2%) of 208 patients with squamous cell carcinoma of the head and neck treated with radiation therapy and ERBITUX, as compared to none of 212 patients treated with radiation therapy alone. Fatal events occurred within 1 to 43 days after the last ERBITUX treatment. Carefully consider the use of ERBITUX in combination with radiation therapy in head and neck cancer patients with a history of coronary artery disease, congestive heart failure or arrhythmias in light of these risks. Closely monitor serum electrolytes including serum magnesium, potassium, and calcium during and after ERBITUX therapy.

Interstitial lung disease (ILD), which was fatal in one case, occurred in 4 of 1570 (