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Vectibix(R) Significantly Improved Progression-Free Survival in Second-Line Treatment of KRAS Wild-Type Metastatic Colorectal Cancer
Date:8/17/2009

THOUSAND OAKS, Calif., Aug. 17 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced positive top-line results from a Phase 3 trial evaluating Vectibix((R) )(panitumumab) in combination with FOLFIRI (an irinotecan-based chemotherapy) as a second-line treatment in 1,186 patients with metastatic colorectal cancer (mCRC). The co-primary endpoints, tested independently, were progression-free and overall survival.

Vectibix significantly improved progression-free survival in combination with FOLFIRI, compared to FOLFIRI alone, in patients with KRAS wild-type mCRC. Although numerically greater, the improvement in median overall survival did not achieve statistical significance in the Vectibix arm.

The addition of Vectibix had no positive or negative effect on progression-free or overall survival in patients with tumors harboring activating KRAS mutations.

"With these data, Vectibix has now demonstrated improved progression-free survival in Phase 3 trials in patients with KRAS wild-type tumors in both first- and second-line treatment of metastatic colorectal cancer," said Roger M. Perlmutter, M.D., Ph.D. executive vice president of Research and Development at Amgen. "These results add to the growing body of evidence confirming the utility of KRAS as a predictive biomarker."

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

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<
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SOURCE Amgen
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