publication date: Jan. 2, 2015
Amgen Cancels Rilotumumab Trials in Gastric Cancer
Amgen ended all of its clinical studies of rilotumumab in advanced gastric cancer, including the phase III RILOMET-1 and RILOMET-2 trials.
The company’s decision was based on a planned safety review by the RILOMET-1 independent data monitoring committee, which found an increase in the number of deaths in the rilotumumab and chemotherapy treatment arm when compared to the chemotherapy-treatment-only arm.
Rilotumumab is an investigational fully-human monoclonal antibody designed to inhibit the hepatocyte growth factor/scatter factor MET pathway, which has the potential to reduce cell proliferation, impair survival signals, and prevent the migration and invasion of tumor cells.
Protocol-defined futility criteria would likely have been met at the planned interim analysis, scheduled for March 2015, according to Amgen, who plan to submit detailed results for presentation and publication.
Amgen is in communication with investigators in rilotumumab studies to coordinate study termination and provide guidance for study subject follow-up.
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