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New England Journal of Medicine Study Shows ERBITUX(R) Improves Survival in Advanced Colorectal Cancer
Date:11/14/2007

- First Study to Demonstrate Survival Benefit with ERBITUX in Patients with

Colorectal Cancer Refractory to All Approved Chemotherapies -

NEW YORK, Nov. 14 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced today results from a multicenter, open-label, randomized Phase III trial, published in the New England Journal of Medicine, in which ERBITUX(R) (cetuximab) as a single agent demonstrated a significant improvement in overall survival in patients with metastatic colorectal cancer (mCRC) refractory to approved chemotherapy agents. The study compared ERBITUX plus best supportive care (BSC) to BSC alone in patients with mCRC whose disease had progressed through treatment with all approved chemotherapy, including irinotecan, oxaliplatin, and fluoropyrimidines.

The independent study (NCIC CTG CO.17), conducted by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) in collaboration with the Australasian Gastro-Intestinal Trials Group (AGITG), involved 572 patients and demonstrated that treating patients with ERBITUX as a monotherapy plus BSC significantly increased overall survival compared to BSC alone. BSC included palliative therapies designed to alleviate pain and treat other effects caused by mCRC.

"This is the first time an antibody used as a single agent in colorectal cancer has demonstrated an overall survival benefit. These outcomes add to the growing body
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SOURCE Bristol-Myers Squibb; ImClone Systems Incorporated
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