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Randomized Phase III Trial Showed Erbitux Significantly Improved,Secondary Endpoints of Progression-Free Survival and Disease,Control in Metastatic Colorectal Cancer Patients

survival between the two arms despite substantial improvement in secondary endpoints.

"We intend to use the results of this study to further understand the potential of ERBITUX in the treatment of colorectal cancer patients." said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb.

The EPIC trial (ERBITUX Plus Irinotecan in Colorectal Cancer) enrolled 1,298 irinotecan-naive mCRC patients whose disease was not responding to first-line oxaliplatin-based chemotherapy. After randomization, patients were treated until their disease progressed. Upon disease progression, study treatment was stopped and further treatment was at the discretion of the physician. Patients who received combination ERBITUX plus irinotecan experienced median overall survival of 10.71 months and median progression- free survival of 4 months; in this treatment group, overall response rate was achieved in 16.4% of patients and 61.4% of patients experienced disease control. Patients who received irinotecan alone experienced median overall survival of 9.99 months and median progression-free survival of 2.6 months; in this treatment group, overall response rate was achieved in 4.2% of patients and 45.8% of patients experienced disease control.

Grade 3/4 adverse events included rash (ERBITUX-irinotecan arm: 8.2% vs. irinotecan arm: 0.5%), infusion reaction (1.4% vs. 0.8%) and hypomagnesemia (3.3% vs. 0.4%). Other common non-hematologic adverse events included: diarrhea (28.8% vs. 16.2%) and fatigue (9.2% vs. 4.9%).

About Colorectal Cancer

In the U.S., approximately 154,000 people will be diagnosed with cancer of the colon or rectum this year. Half of these patients have metastatic disease, or cancer that has spread to other organs, at the time of diagnosis. EGFR is expressed in up to 77.7 % of colorectal cancer tumors. Colorectal cancer is the third most common cancer in both men and women.

About ERBITUX(R) (Cetuximab)<
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