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Denosumab Demonstrates Superiority Over Zometa(R) in Delay of Complications Due to Bone Metastases in Advanced Breast Cancer Patients
Date:9/22/2009

g a lower incidence of renal toxicity and acute phase reactions, combined with the convenience of a monthly subcutaneous injection. Denosumab would be a welcome new treatment option for advanced breast cancer patients."

Denosumab also delayed the median time to first on-study SRE or hypercalcemia of malignancy (HCM) compared to Zometa (hazard ratio 0.82, 95 percent CI: 0.70, 0.95; p=0.007). The median time to first on-study SRE or HCM was not reached for denosumab and therefore could not be estimated. The median time to first on-study SRE or HCM was 25.2 months for Zometa.

Bone pain can dominate the daily lives of patients with metastatic disease involving bone and is often characterized as severe or intolerable.(1) In a pre-specified exploratory analysis, patients on the denosumab arm reported worsening of pain later than those on the Zometa arm (88 days versus 64 days, respectively; hazard ratio 0.87, 95 percent CI: 0.79, 0.97; p=0.009).

Overall, the incidence of adverse events (96 percent denosumab, 97 percent Zometa) and serious adverse events (44 percent denosumab, 46 percent Zometa) was consistent with what has previously been reported for these two agents. Adverse events potentially associated with renal toxicity occurred in 4.9 percent of patients treated with denosumab compared to 8.5 percent in patients treated with Zometa. Osteonecrosis of the jaw (ONJ) was seen infrequently in both treatment groups (20 patients receiving denosumab (2.0 percent) as compared with 14 patients (1.4 percent) receiving Zometa). There was no statistically significant difference in the rate of ONJ between the two treatment arms. Overall survival (hazard ratio 0.95, 95 percent CI: 0.81, 1.11; p=0.50) and time to cancer progression (hazard ratio 0.99, 95 percent CI: 0.89, 1.11; p=0.90) was balanced between treatment arms.

Detailed data from another Phase 3, head-to-head trial evaluating denosumab v
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SOURCE Amgen
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Prepared by multi-temperature ethanol fractionation with extensive charcoal treatment and dialysis.• Assay: ≥ 95 % (HPCE)• pH ~5.2 (10 mg/mL in 0.15 M NaCl)...
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