Amgen's Vectibix meets main goal of Phase III trial in mCRC

Amgen on Thursday announced that Vectibix (panitumumab) plus best supportive care (BSC) met the primary endpoint of a Phase III trial by significantly improving overall survival (OS) in patients with chemorefractory wild-type exon 2 KRAS metastatic colorectal cancer (mCRC), compared with BSC alone. In addition, the company said the Vectibix arm showed statistical significance for all key secondary endpoints, including OS in mCRC patients with wild-type RAS who do not have mutations in exons 2, 3 and 4 of the KRAS and NRAS genes.

Study '0007 randomised 377 patients to receive Vectibix administered intravenously every 14 days plus BSC, or BSC alone. According to Amgen, adverse events in Vectibix-treated patients were consistent with the therapy's known safety profile. Full results of the study will be presented at a future medical meeting and submitted for publication.

"The Vectibix clinical programme continues to underscore the importance of identifying options for patients based on their cancer's genetic makeup," said Sean Harper, executive vice president of R&D at Amgen, adding that "these positive overall survival results…reinforce the importance of KRAS and RAS biomarkers in making treatment decisions in metastatic colorectal cancer."

In May 2014, the FDA expanded the indication for Vectibix to include use in combination with FOLFOX as a first-line treatment for patients with wild-type exon 2 KRAS mCRC.

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