November 24, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
Biopharma giant Amgen fell Monday after announcing that it was terminating all Amgen-sponsored clinical studies of gastric cancer drug rilotumumab after the deaths of some enrolled subjects, including two Phase III trials being closely watched by Wall Street analysts and company shareholders.
The company said the two studies, dubbed RILOMET-1 and RILOMET-2, had not met safety standards during a planned safety review by the data monitoring company. The committee found an increase in death in the rilotumumab and chemotherapy arm of the study compared to the chemotherapy arm alone. Amgen said the protocol-defined futility criteria would likely have been met at the planned interim analysis set 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 for Amgen, in a statement. “There is a high unmet need for new treatments to address advanced gastric cancer, one of the leading causes of death worldwide.”
Rilotumumab is an investigational fully-human monoclonal antibody designed to inhibit the hepatocyte growth factor/scatter factor (HGF/SF): MET pathway. The drug is hoped to reduce cell growth, thus stopping the growth of existing cancer and stopping the spread of further tumor cells.
Amgen said it would work with investigators to coordinate study termination and provide guidance for study subject follow-up.
