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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

- As previously announced, primary endpoint not met; plausibly confounded by survival benefit of post-study treatment with ERBITUX -

NEW YORK, April 16, 2007 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated and Bristol-Myers Squibb Company today announced detailed results from the EPIC study - a randomized, open-label, multi-center Phase III trial - comparing ERBITUX(R) (Cetuximab) plus irinotecan to irinotecan alone in patients with metastatic colorectal cancer (mCRC) who failed first-line therapy. Results showed that the secondary endpoints of progression-free survival and response rate were significantly higher in the ERBITUX-irinotecan arm. The median time of survival without disease progression was improved by 54% in the patients who received ERBITUX plus irinotecan. This benefit produced a significant 31% reduction in the risk of disease progression (Hazard ratio, 0.692; 95% CI = 0.617- 0.776; p<0.0001). Additionally, patients in the ERBITUX-irinotecan arm were four times more likely to experience a 50% reduction in tumor size over patients treated with irinotecan alone (p<0.0001).

"The improvement in progression-free survival and response rate expands our understanding of the significant activity of ERBITUX," said Eric Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems. "We believe these outcomes add to the existing clinical evidence demonstrating the safety and effectiveness of ERBITUX in combination with chemotherapy."

As previously reported, the study's primary endpoint of overall survival was not different between the two groups (Hazard ratio, 0.975; 95.03% CI = 0.854 - 1.114; p=0.7115). Analysis of the data show that a considerable number of patients randomized to the irinotecan arm went on to receive ERBITUX with or without irinotecan after failing irinotecan alone. Extensive post-trial use of ERBITUX may explain the lack of difference in overall
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