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;>

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;>

Detailed data from another Phase 3, head-to-head trial evaluating denosumab versus Zometa was presented yesterday (Abstract #20LBA). In this study of 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma, denosumab met its primary endpoint and demonstrated non-inferiority compared to Zometa in the treatment of bone metastases.

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