THOUSAND OAKS, Calif., Nov. 24, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today 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.
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 committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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1 World Health Organization, GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed November 2014.
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