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Published Results Show Denosumab Superior to Zometa® in Delaying or Preventing Bone Complications in Patients With Bone Metastases From Advanced Breast Cancer
Date:11/8/2010

THOUSAND OAKS, Calif., Nov. 8, 2010 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced the publication of results from a pivotal Phase 3 study of 2,046 patients which compared denosumab with Zometa® (zoledronic acid) in delaying or preventing skeletal-related events (SREs) in breast cancer patients with bone metastases. An SRE consists of any of the following: a pathologic fracture, the need for radiation or surgery to ameliorate bone pathology secondary to tumor growth, or spinal cord compression.  The study, published today in the Journal of Clinical Oncology, found that denosumab was superior to Zometa in delaying or preventing SREs in breast cancer patients with bone metastases.

"Patients with bone metastases from cancer are at increased risk of experiencing debilitating pathologic fractures and other skeletal-related events. The results of this study show that denosumab is better than the current standard of care (Zometa) in delaying or preventing these skeletal complications for our patients with advanced breast cancer," said Alison Stopeck, M.D., associate professor of Medicine, Arizona Cancer Center, University of Arizona Health Sciences Center. "In addition to improving skeletal outcomes, denosumab has no requirement for renal monitoring and is administered as a simple subcutaneous injection."

Study ResultsIn the study, denosumab was superior to Zometa in delaying time to first on-study SRE (hazard ratio [HR] 0.82; 95 percent CI: 0.71-0.95; P=0.01 superiority) and time to first and subsequent (multiple) SREs (rate ratio 0.77; 95 percent CI: 0.66-0.89; P=0.001).  Reduction in bone turnover markers was greater with denosumab.  

The incidence of adverse events (AEs) (96 percent denosumab, 97 percent Zometa) and serious AEs (44 percent denosumab, 46 percent Zometa) was consistent with what has previo
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SOURCE Amgen
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