Amgen: New Biomarker Data Links KRAS Gene to Vectibix(TM) Clinical Response

BARCELONA, Spain--(BUSINESS WIRE)--Amgen (NASDAQ: AMGN) today announced the results of a biomarker analysis that supports KRAS as a predictive clinical biomarker that could be used to select patients who are more likely to respond to treatment with Vectibix™ (panitumumab) monotherapy. These data were generated from an analysis of the Phase 3, randomized, controlled clinical trial that investigated the treatment effect of Vectibix in patients with metastatic colorectal cancer (mCRC). Previously reported results from this study demonstrated that Vectibix monotherapy improved progression-free survival ((PFS), HR 0.54; p<0.001)) and response rate (10 percent versus 0 percent) in heavily pre-treated patients with mCRC after failure of standard chemotherapy. The new biomarker analysis met its primary and secondary endpoints by demonstrating that the effect of Vectibix on PFS was confined exclusively to the approximately 60 percent of patients whose tumors harbor normal, non-mutated (wild-type) KRAS. No effect of Vectibix therapy was observed in patients who had tumors with mutations in KRAS regardless of the endpoint studied. These data have been shared with U.S. and global regulatory agencies and have been submitted for peer-reviewed publication.

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