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Vectibix(R) in Combination With Chemotherapy Significantly Improves Progression-Free Survival in First-Line Metastatic Colorectal Cancer
Date:9/24/2009

THOUSAND OAKS, Calif., Sept. 24 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced detailed results from the Phase 3 '203' trial evaluating Vectibix(R) (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as the first-line treatment of metastatic colorectal cancer (mCRC). In this trial, Vectibix significantly improved median progression-free survival (PFS) by 1.6 months (9.6 versus 8.0 months for patients treated with FOLFOX alone, (hazard ratio 0.80; p=0.02)) in patients with KRAS wild-type mCRC (primary endpoint). The results were presented at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany (Abstract Number 10LBA).

Further, the addition of Vectibix to chemotherapy also improved response rate in the KRAS wild-type patient population as measured by blinded central review (55 percent versus 48 percent in the FOLFOX only arm).

"I am very pleased with the outcome of this high quality trial which demonstrated that Vectibix improved progression-free survival and appeared to be well tolerated as a first-line metastatic colorectal cancer treatment in a selected patient population," said Jean-Yves Douillard, director Clinical and Translational Research, Medical Oncology Branch, Centre R Gauducheau, France and the study's principal investigator. "This is the first prospective Phase 3 data to demonstrate the importance of KRAS mutation as a predictive biomarker for Vectibix treatment in the first-line setting, providing definitive support for the use of the KRAS biomarker for selection of patients eligible for anti-EGFR therapy."

Importantly, in patients with tumors harboring activating KRAS mutations, PFS was significantly inferior in the V
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SOURCE Amgen
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