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.
, 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
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
of an initial dose of intravenous cetuximab, followed by 250 mg/m
of intravenous cetuximab every seven days.
Results from studies performed over the last 30 years indicate that
plays an important role in cell growth regulation. In mCRC, EGFR transmits signals through a set of intracellular proteins. Upon reaching the nucleus, these signals instruct the cancer cell to reproduce and metastasize, leading to cancer progression.
Anti-EGFR antibody therapies work by inhibiting the activation of EGFR, thereby inhibiting downstream events that lead to malignant signaling. However, in patients whose tumors harbor a mutated
gene, the KRAS protein is always turned "on," regardless of whether the EGFR has been activated or therapeutically inhibited. Common
mutations occurring in exon 2 (codons 12/13) are present in approximately 40 to 50 percent of mCRC patients.
Vectibix is the first fully human anti-EGFR antibody approved by
the United States
(U.S.) Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix was approved in the U.S. in
as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing mCRC is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.