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Amgen terminates all company-sponsored trials of rilotumumab in advanced gastric cancer

Amgen has terminated all of the company-sponsored clinical trials of rilotumumab, an investigational fully-human monoclonal antibody, in advanced gastric cancer including the Phase III RILOMET-1 and RILOMET-2 trials.

The decision to terminate the trials 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.

The company said that protocol-defined futility criteria would likely have been met at the planned interim analysis, scheduled for March 2015.

Detailed results of RILOMET-1 will be submitted for presentation and publication.

Amgen executive vice-president of Research and Development Sean Harper said: "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.

"There is a high unmet need for new treatments to address advanced gastric cancer, one of the leading causes of cancer death worldwide."

Currently, the company is in communication with investigators in rilotumumab trials to coordinate study termination and provide guidance for study subject follow-up.

Rilotumumab is 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.