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Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)
Date:8/3/2009

THOUSAND OAKS, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced positive top-line results from a pivotal Phase 3 head-to-head trial evaluating denosumab administered subcutaneously versus Zometa((R)) (zoledronic acid) administered as an intravenous (IV) infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma.

For the primary endpoint, patients treated with denosumab experienced a similar time to first skeletal-related event (SRE) (fracture, radiation to bone, surgery to bone, or spinal cord compression) compared with those 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 with denosumab treatment was not statistically superior compared to Zometa (adjusted p=0.06) (secondary endpoint). The time to first-and-subsequent SRE was also numerically greater but not statistically superior compared to Zometa (hazard ratio 0.90, 95 percent CI: 0.77-1.04) (secondary endpoint).

Overall, the incidence of adverse events and serious adverse events was consistent with what has previously been reported for these two agents. Rates of osteonecrosis of the jaw (ONJ) were balanced and infrequent in both treatment groups (10 patients receiving denosumab as compared with 11 patients receiving Zometa). 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 these results, which continue to demonstrate that inhibiting RANK Ligand with denosumab provides a clinically meaningful benefit for adva
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SOURCE Amgen
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