In the safety analysis, the profiles of both treatments were consistent with previously reported studies. Adverse events (AEs) included known events such as rash, low levels of magnesium in the blood and infusion reactions.
In Europe, the ASPECCT trial is a Specific Obligation for Vectibix as part of the European Medicine Agency's (EMA) conditional marketing authorization.
ASPECCT ('763) Trial Design
ASPECCT is a global, randomized, multicenter, open-label, Phase 3 non-inferiority trial designed to compare the effect of panitumumab versus cetuximab on overall survival for monotherapy treatment of chemorefractory metastatic colorectal cancer (mCRC) in 999 patients with wild-type
KRAS tumors (primary endpoint). Secondary endpoints included safety, patient reported outcomes, progression-free survival, time to response, time to treatment failure and duration of response.
Patients were randomized in a 1:1 ratio to receive 6 mg/kg of intravenous panitumumab every 14 days or 400 mg/m 2 of an initial dose of intravenous cetuximab, followed by 250 mg/m 2 of intravenous cetuximab every seven days.
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