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Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases
Date:7/7/2009

THOUSAND OAKS, Calif., July 7 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events (SREs)(fracture, radiation to bone, surgery to bone, or spinal cord compression) (hazard ratio 0.82, 95 percent CI: 0.71, 0.95), and delaying the time to the first-and-subsequent SREs (hazard ratio 0.77, 95 percent CI: 0.66, 0.89). Both results were statistically significant.

Overall, the incidence of adverse events and serious adverse events was consistent with what has previously been reported for these two agents. Of note, osteonecrosis of the jaw (ONJ), which had not been observed in previously reported Phase 3 studies with denosumab, was seen infrequently in both treatment groups. There was no statistically significant difference in the rate of ONJ between the two treatment arms. Infectious adverse events were balanced between the two treatment arms, as was overall survival and the time to cancer progression.

"We are extremely pleased with the outcome of this important study, which shows that denosumab can reduce or delay the serious complications of bone metastases in breast cancer patients better than the current standard of care, and with a favorable benefit/risk profile," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "These results underscore the importance of the RANK Ligand pathway in bone disease, and offer the promise of improved care for patients with advanced breast cancer. We look forward to
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SOURCE Amgen
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