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The Journal of Clinical Oncology Publishes Phase 3 XGEVA™ (Denosumab) Results in Advanced Cancer Patients With Solid Tumors or Multiple Myeloma
Date:2/22/2011

THOUSAND OAKS, Calif., Feb. 22, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced the publication of results from a pivotal Phase 3 study of 1,776 advanced cancer patients with different types of solid tumors (not including breast and prostate cancer) or multiple myeloma, which compared XGEVA(denosumab) to Zometa® (zoledronic acid) in preventing skeletal-related events (SREs). The study, which appeared today in the Journal of Clinical Oncology, found that XGEVA was non-inferior to Zometa in delaying or preventing SREs.

"Almost every type of cancer has the potential to spread to the bone, putting patients at risk for devastating bone complications, like fracture or compression of the spinal cord," said David H. Henry, M.D., clinical professor of medicine, Pennsylvania Hospital, Philadelphia, PA. "Once a patient has bone metastases one of our major goals is to prevent events like fracture or spinal cord compression. XGEVA is an important new option to help prevent these debilitating complications."

XGEVA, the first and only RANK Ligand inhibitor indicated for the prevention of SREs in patients with bone metastases from solid tumors was approved by the U.S. Food and Drug Administration (FDA) on Nov. 18, 2010.  The approval was based in part on results described in this publication. XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma.

Key Study ResultsFor the primary endpoint of this study, the median time to first on-study SRE (defined as fracture, radiation to bone, surgery to bone, or spinal cord compression) was 20.6 months for patients receiving XGEVA and 16.3 months for patients receiving Zometa (hazard ratio 0.84, 95 percent CI: 0.71-0.98), which is statistically significant for non-inferiority (p=0.0007). Although numerically greater, the delay in the time to first SRE associated wi
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