Amgen Inc. (AMGN) announced that it has terminated all of its sponsored clinical studies of rilotumumab in advanced gastric cancer, including the Phase 3 RILOMET-1 and RILOMET-2 studies.
The company noted that its decision was based on a planned safety review by the RILOMET-1 independent data monitoring committee that found an increase in the number of deaths in the rilotumumab and chemotherapy treatment arm when compared to the chemotherapy treatment only arm.
The company noted that Protocol-defined futility criteria would likely have been met at the planned interim analysis, scheduled for March 2015.
"While we are disappointed with these results, we will work with lead investigators to further analyze the data in order to help inform future research and therapies in this area," said Sean Harper, executive vice president of Research and Development at Amgen.
Rilotumumab is an investigational fully-human monoclonal antibody designed to inhibit the hepatocyte growth factor/scatter factor (HGF/SF):MET pathway, which has the potential to reduce cell proliferation, impair survival signals, and prevent the migration and invasion of tumor cells.
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