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Amgen Terminates All Clinical Studies of Rilotumumab in Advanced Gastric Cancer

Monoclonal antibody increases number of deaths in phase III trial

Amgen has announced the termination of all company-sponsored clinical studies of rilotumumab in advanced gastric cancer, including the phase III RILOMET-1 and RILOMET-2 studies.

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-plus-chemotherapy arm compared with the chemotherapy-only arm. Protocol-defined futility criteria would likely have been met at the planned interim analysis, scheduled for March 2015.

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

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, to impair survival signals, and to prevent the migration and invasion of tumor cells.

In an exploratory analysis of phase II data conducted in 2012, the addition of rilotumumab to chemotherapy in patients with gastric tumors with high MET expression improved median overall survival from 5.7 months to 11.1 months (hazard ratio [HR], 0.29). Conversely, in patients with gastric tumors with low MET expression, the addition of rilotumumab to chemotherapy was associated with a trend toward unfavorable overall survival (HR, 1.84). These results led Amgen to plan a phase III study to confirm the efficacy of rilotumumab in patients with advanced gastric and gastroesophageal cancer with high MET expression.

Gastric cancer is the second most common cause of cancer-related death in the world, accounting for 736,000 deaths worldwide in 2008. An estimated 21,320 new cases of gastric cancer were diagnosed in the U.S. in 2012, and approximately 10,540 Americans died from the disease. Gastric cancer mostly affects older people, with nearly two-thirds of patients aged 65 years or older.

Sources: Amgen; November 24, 2014; and Amgen; May 16, 2012.

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