A randomized, phase II, multicenter, double-blind, placebo-controlled study evaluating onartuzumab (MetMAb) in combination with mFOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer.

TPS3640 Background: Dysregulation of the HGF/Met (Met) pathway has been linked with poor prognosis in colorectal cancer. Crosstalk between the Met and vascular endothelial growth factor (VEGF) pathways may be important during tumorigenesis. Aberrant activation of the HGF/Met pathway may promote angiogenesis via tumor cell secretion of angiogenic factors or directly activating endothelial cells. Onartuzumab (MetMAb) is a monovalent, monoclonal antibody that specifically binds to the Met receptor. The combination of onartuzumab and VEGF inhibition in preclinical models resulted in enhanced antitumor activity over either treatment alone. Preclinical efficacy data support the combination of onartuzumab with platinum agents. In phase I studies, onartuzumab has been generally well tolerated alone and in combination with bevacizumab. Adverse events most commonly associated with onartuzumab are peripheral edema and fatigue. Methods: This is a randomized, two-arm, phase II study in patients with previously untreat...