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Colorectal Cancer Drug Panitumumab (Vectibix) Improves Survival in Late-Stage Study
A phase III trial evaluating panitumumab (Vectibix, Amgen) plus best supportive care (BSC) has met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared with patients treated with BSC alone.
In addition, the panitumumab-treated patients showed statistical significance for all key secondary endpoints, including OS in patients with wild-type RAS (absence of mutations in exons 2, 3, and 4 of KRAS and NRAS) mCRC.
Colorectal cancer is the third most common cancer worldwide, with approximately 1.2 million cases occurring globally each year. In the U.S., colorectal cancer is the second leading cause of cancer-related deaths, with an estimated 132,700 new cases diagnosed in 2015.
The new phase III, randomized, open-label trial was designed to evaluate the survival benefit of panitumumab and BSC compared with BSC alone in patients with chemorefractory wild-type KRAS (exon 2) mCRC. Patients were randomly assigned to receive either panitumumab (6 mg/kg every 14 days) and BSC, or BSC alone.
Panitumumab is the first fully human anti-epidermal growth factor receptor (EGFR) antibody approved by the FDA for the treatment of mCRC. The drug was approved in the U.S. in 2006 as monotherapy for patients with EGFR-expressing mCRC after disease progression following prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.
In 2014, the FDA also approved panitumumab for use in combination with FOLFOX (folinic acid [leucovorin], fluorouracil [5-FU], and oxaliplatin [Eloxatin]), one of the most commonly used chemotherapy regimens, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, panitumumab became the only biologic therapy indicated for use with FOLFOX in the first-line treatment of mCRC for patients with wild-type KRAS mCRC.
Source: Amgen; June 18, 2015.