Phase III trial of Vectibix (panitumumab) meets endpoint in colorectal cancer-Amgen

Amgen has announced that a Phase III study evaluating Vectibix (panitumumab) and best supportive care (BSC) 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 to those patients treated with BSC alone. The Vectibix treatment arm further 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. In the Vectibix treatment arm, the observed adverse events were consistent with the known Vectibix safety profile.Full results will be submitted to a future medical congress and for publication.

Comment: Study '0007 (NCT01412957) is a Phase III global, multicenter, randomized, open-label study designed to evaluate the survival benefit of Vectibix and best supportive care (BSC) compared to BSC alone in patients with chemorefractory wild-type KRAS (exon 2) mCRC.

Comment: The positive results reinforced the importance of KRAS and RAS biomarkers in mCRC. Vectibix has been approved for EGFR expressing mCRC following disease progression and prior chemotherapy and also is approved for use in combination with FOLFOX chemotherapy as first line treatment in patients with wild-type KRAS (exon 2) disease.