Amgen announced that the phase 3 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 tumours (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 per cent CI: 0.839, 1.113) favouring 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, diarrhoea and hypomagnesemia.
Colorectal cancer is the third most common cancer found in both men and women in the US, and is the second leading cause of cancer deaths. Approximately 1.2 million cases of colorectal cancer are expected to occur globally.
Detailed safety and efficacy data will be submitted for presentation at an upcoming medical meeting later this year.
ASPECCT is a global, randomized, parallel assignment, open-label, Phase 3 non-inferiority trial designed to compare the effect of Vectibix versus Erbitux on overall survival for monotherapy treatment of chemorefractory mCRC in 1,010 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 Vectibix every 14 days or 400 mg/m2 of an initial dose of intravenous Erbitux followed by 250 mg/m2 of intravenous Erbitux every seven days.
In Europe, the ASPECCT trial is a Specific Obligation for Vectibix as part of the European Medicine Agency's (EMA) conditional marketing authorization.
Vectibix is the first fully human anti-epidermal growth factor receptor (EGFR) antibody approved by the US Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer (mCRC). Vectibix was approved in the US in September 2006 as a single agent for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin and irinotecan chemotherapy regimens. Approval is based on progression-free survival; no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient.