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Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer
Date:8/6/2009

THOUSAND OAKS, Calif., Aug. 6 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that Vectibix((R)) (panitumumab), administered in combination with FOLFOX (an oxaliplatin-based chemotherapy), significantly prolonged progression-free survival (PFS) compared with FOLFOX alone in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer (mCRC).

"We believe that these data document an important advance for patients with metastatic colorectal cancer," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "These are the first prospective Phase 3 data to demonstrate the utility of KRAS mutational analysis as a predictive biomarker."

Overall, the adverse event profile was as anticipated for an anti-EGFR antibody in combination with oxaliplatin-based chemotherapy, including known events such as skin toxicity, hypomagnesemia and diarrhea.

Originally designed to compare the treatment effect in the overall population, the study was amended to analyze outcomes with respect to the presence or absence of activating mutations in KRAS in the tumor itself. Tumor KRAS status was ascertained in more than 90 percent of the 1,183 patients enrolled in the trial.

Importantly, in patients with tumors harboring activating KRAS mutations, PFS was significantly inferior in the Vectibix arm. These data confirm previous findings when oxaliplatin-based chemotherapy and an anti-EGFR antibody are combined.

"Our study underscores the importance of KRAS status in identifying the appropriate patient population to be treated with Vectibix, consistent with worldwide labeling," said Perlmutter. "Not only is the improvement in progress
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SOURCE Amgen
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