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Final Vectibix Positive Pivotal Phase 3 Trial Results In Metastatic,Colorectal Cancer Patients Published

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Apr 30, 2007 - Amgen (NASDAQ:AMGN), today announced final results from a pivotal Phase 3 trial which showed that Vectibix(TM) (panitumumab), a fully human monoclonal antibody directed against the epidermal growth factor receptor (EGFr), prolonged progression-free survival (PFS) compared to best supportive care (BSC) in metastatic colorectal cancer patients who had failed fluoropyrimidine, irinotecan, and oxaliplatin containing chemotherapy regimens. The results were published in the May issue of the Journal of Clinical Oncology.

"Medical advances in the treatment of first- and second-line colorectal cancer have improved survival rates; however, most patients develop resistance to these therapies, creating the need for an active agent to treat patients with advanced disease," said Professor Eric Van Cutsem, M.D., Ph.D., Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium, lead author of the manuscript. "Final results from the first large randomized trial of its kind show that Vectibix provides a benefit in this heavily pre-treated patient population."

The September 2006 Food and Drug Administration (FDA) approval of Vectibix was based on the results from this multi-national, open-label, randomized study of 463 patients. Patients were randomized to receive 6 mg/kg Vectibix plus BSC (n=231) every two weeks or BSC alone (n=232) until disease progression or unacceptable toxicity. An independent, central radiology review board assessed disease progression and tumor shrinkage. BSC patients determined to have disease progression were eligible to cross-over to a separate study and receive Vectibix.

The primary endpoint of this study was an improvement in progression-free survival. Co-secondary study endpoints were best objective response by blinded central review and overall survival time. The effectiveness of Vectibix for the treatment of EGFr
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