Vectibix-Avastin Combination Trial in Colorectal Cancer Fails

Amgen's clinical program to expand Vectibix's use as a first- and second-line treatment for metastatic colorectal cancer is not affected by the discontinuation of the Avastin-Vectibix combination trial, which was halted due to efficacy and safety concerns.

The company said that two Phase III registration studies assessing Vectibix (panitumumab) in combination with chemotherapy regimens in the first- and second-line treatment settings will not be affected by the trial cancellation. The firm anticipates publication of results for these Phase III studies in 2009 or 2010.

Amgen announced late last month that it halted the Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) open-label study following an interim analysis that identified an excess of Grade 3 adverse events in the investigational arm versus the control arm.

PACCE tested Vectibix in combination with Avastin (bevacizumab) and chemotherapy in the first-line metastatic colorectal cancer treatment setting. Avastin plus chemotherapy is the current standard of care.

"This analysis revealed a statistically significant difference in progression-free survival in favor of the control arm. An unplanned analysis of overall survival also demonstrated a statistically significant difference favoring the control arm," Amgen said.