Amgen announced the termination of all Amgen-sponsored clinical studies of rilotumumab in advanced gastric cancer,  including the Phase 3 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.  Detailed results of RILOMET-1 will be submitted for presentation and publication.

“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.  “There is a high unmet need for new treatments to address advanced gastric cancer, one of the leading causes of cancer death worldwide1.”

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

Source: Amgen