publication date: Aug. 4, 2015
Vectibix Improves OS in Phase III Trial of mCRC
A phase III study of Vectibix (panitumumab) in metastatic colorectal cancer met its primary endpoint of improving overall survival.
The trial evaluated Vectibix and best supporting care in patients with chemorefractory wild-type KRAS (exon 2) metastatic disease compared to treatment with best supporting care alone. Full results will be submitted to a future medical congress and for publication, according to the trial’s sponsor, Amgen.
The Vectibix treatment arm further showed statistical significance for all secondary endpoints including OS and PFS in patients with wild-type RAS (absence of mutations in exons 2, 3 and 4 of KRAS and NRAS) mCRC. Observed adverse events were consistent with the known Vectibix safety profile.
In the global, randomized, open-label study, patients were randomized 1:1 to receive 6 mg/kg of Vectibix every 14 days and BSC, or BSC alone (as defined by the investigator).
Vectibix is the first fully human anti-EGFR antibody approved by the FDA for the treatment of metastatic colorectal cancer. Vectibix was approved in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.
In May 2014, the FDA approved Vectibix for use in combination with FOLFOX, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in the first-line treatment of mCRC for patients with … Continue reading CCL July – Vectibix Improves OS in Phase III Trial of mCRC
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