Amgen (AMGN) Updates on Exploratory Biomarker Analysis for AMG 102 Response Predictor
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Amgen (Nasdaq: AMGN) reports results from an exploratory biomarker analysis evaluating MET expression as a predictor of clinical response to rilotumumab (AMG 102). This analysis, conducted on a previously reported Phase 2 study of rilotumumab in patients with locally advanced or metastatic gastric or gastroesophageal cancer, showed that treatment with rilotumumab in combination with chemotherapy improved median overall survival (OS) in patients whose tumors exhibited high MET protein expression. Full results of the study will be presented in an oral presentation at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 2 (Abstract 4005, 4:45 p.m. - 5:00 p.m. CDT, E Hall D1).
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 Amgen to plan a Phase 3 study to confirm the efficacy of rilotumumab in advanced gastric and gastroesophageal cancer with high MET expression.
"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 Michael Severino, M.D., senior vice president, global development and corporate chief medical officer at Amgen. "Personalized medicine has the potential to transform cancer care, and by leveraging our understanding of biology and the mechanism of disease, we hope to identify safe and effective new treatments for patients who aren't well-served by current therapies."
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 Amgen to plan a Phase 3 study to confirm the efficacy of rilotumumab in advanced gastric and gastroesophageal cancer with high MET expression.
"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 Michael Severino, M.D., senior vice president, global development and corporate chief medical officer at Amgen. "Personalized medicine has the potential to transform cancer care, and by leveraging our understanding of biology and the mechanism of disease, we hope to identify safe and effective new treatments for patients who aren't well-served by current therapies."
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