Amgen has terminated all Amgen-sponsored clinical studies of rilotumumab in advanced gastric cancer, including the Phase III RILOMET-1 and RILOMET-2 studies. Amgen’s decision is 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. 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 E. Harper, M.D., executive vice president of research and development at Amgen, in a company release. “There is a high unmet need for new treatments to address advanced gastric cancer, one of the leading causes of cancer death worldwide.”

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. Amgen is in communication with investigators in rilotumumab studies to coordinate study termination and provide guidance for study subject follow-up.

Source: Amgen