ASPECCT study of Vectibix (Amgen) compared to Erbitux in treatment of Colorectal Cancer
Amgen announced that the Phase III head-to-head ASPECCT ('763) trial evaluating Vectibix (panitumumab) versus Erbitux (cetuximab) as a single agent for the treatment of chemorefractory metastatic Colorectal Cancer (mCRC) in patients with wild-type KRAS tumors (n=1,010) met its primary endpoint of non-inferiority for overall survival. The estimated overall survival hazard ratio (Vectibix/Erbitux) was 0.966 (95 percent CI: 0.839, 1.113) favoring the Vectibix arm.Overall, the relative adverse event profiles were as anticipated for each of the anti-EGFR therapies studied, including known events such as rash, diarrhea and hypomagnesemia.
In Europe , the ASPECCT trial is a Specific Obligation for Vectibix as part of the European Medicine Agency's (EMA) conditional marketing authorization.