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Extensive Clinical Data on Erbitux Presented at the 2007 ASCO,Annual Meeting

e for patients versus those patients receiving irinotecan alone. In NCIC CO. 17, ERBITUX, when used as a single agent in a refractory patient population, significantly improved overall survival and provided a superior quality of life for patients versus those patients receiving best supportive care.

Head and Neck Cancer (H&N) Highlights

Results from EXTREME, a large randomized Phase III study, also conducted by Merck KGaA, in first line recurrent and/or metastatic head and neck (mH&N) cancer, demonstrated that patients who received ERBITUX and platinum based chemotherapy experienced a significant improvement in overall survival versus chemotherapy alone.

"We are very excited by the findings of this trial as they demonstrate that ERBITUX provides a survival benefit across the continuum of care for patients with head and neck cancer. ERBITUX now offers patients a survival advantage in advanced local regional disease and in the metastatic setting," said Eric K. Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems. "Importantly, the survival time reported in this study is the longest ever seen in this metastatic patient population."

The EXTREME trial included more than 440 patients with stage III/IV mH&N. The primary endpoint was overall survival. Analyses of secondary endpoints such as progression-free survival, response rate, disease control rate, safety, and quality of life are currently ongoing.

Non Small Cell Lung Cancer (NSCLC)

Encouraging outcomes were reported at ASCO from two Phase II randomized trials in the treatment of naive (first-line) advanced NSCLC. In one of these studies, favorable overall survival, progression-free survival, response rate and safety were observed when ERBITUX was added to gemcitabine and a platinum-based chemotherapy. In the other NSCLC study, ERBITUX, when used in combination with or following carboplatin and paclitaxel therapy, met the prespecified g
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