Analysis Of Rilotumumab (AMG 102) Data Identifies A Potential Predictive Biomarker For Patients With Gastric Or Gastroesophageal Cancer
Rilotumumab is an investigational fully human monoclonal antibody designed to inhibit the hepatocyte growth factor/scatter factor (HGF/SF): MET pathway. In this exploratory analysis, the addition of rilotumumab to chemotherapy in patients with gastric tumors with high MET expression improved median OS from 5.7 months to 11.1 months (HR = 0.29, 95 percent CI, 0.11 - 0.76). Conversely, in patients with gastric tumors with low MET expression, the addition of rilotumumab to chemotherapy was associated with a trend towards unfavorable OS (HR = 1.84, 95 percent CI, 0.78 - 4.34). These results have led
"These data are the first to demonstrate a potential biomarker for treatment with rilotumumab in gastric cancer, the second leading cause of cancer deaths worldwide," said
Primary results of the study were presented at the 2011
The most common adverse events seen in the rilotumumab plus chemotherapy arms included peripheral edema, neutropenia, anemia, thrombocytopenia and deep vein thrombosis. There were no major differences in adverse events between the two rilotumumab arms.
In addition to the results from this study, data from studies of 12
Phase 2 Study Design
In this Phase 2, three-arm trial, 121 patients were randomized 1:1:1 to receive epirubicin, cisplatin and capecitabine (50mg/m(2) IV day 1, 60mg/m(2) IV day 1, 625mg/m(2) BID orally days 1-21, respectively) in combination with two different dose levels of rilotumumab (Arm A 15 mg/kg Q3W, n=40; Arm B 7.5 mg/kg Q3W, n=42) or placebo (Arm C, n=39). The primary endpoint of the study was PFS. Secondary endpoints included OS, objective response rate (ORR) and safety. In the biomarker analysis, 90 patients were evaluated for MET protein levels using an immunohistochemistry test. Twenty-seven patients from the rilotumumab treatment arms and 11 patients who received placebo were found to have tumors with high MET expression, defined as greater than 50 percent of tumor cells testing positive for the MET protein.
About Gastric Cancer
Gastric, or stomach, cancer is the second most common cause of cancer-related death in the world, accounting for 736,000 deaths worldwide in 2008. The highest mortality rates are in Eastern Asia. An estimated 21,320 new cases of gastric cancer will be diagnosed in
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Christine Regan, 805-447-5476 (Media)
Arvind Sood, 805-447-1060 (Investors)
 Stomach Cancer.
 Stomach Cancer.