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Integrated Analysis Demonstrates That Denosumab Delays the Onset of Bone Complications Compared to Zometa®
Date:10/10/2010

ed analysis of these trials, which together enrolled more than 5,700 patients, provided a clear view of the efficacy and safety profile of denosumab in a large and diverse group of people living with cancer and bone metastases.

The analysis showed that denosumab was superior to Zometa in delaying time to first on-study SRE by 17 percent (median time to first skeletal related event of 27.7 months for denosumab and 19.5 months for Zometa, p <0.0001). Denosumab was also superior to Zometa in delaying time to first-and-subsequent on-study SRE by 18 percent (p<0.0001). Overall disease progression and survival were similar for both groups.

Overall, the occurrence of adverse events (96.2 percent denosumab, 96.8 percent Zometa) and serious adverse events (56.3 percent denosumab, 57.1 percent Zometa) were balanced in both groups and consistent with what has previously been reported for these two agents.

Osteonecrosis of the jaw (ONJ) occurred infrequently, 1.8 percent of denosumab patients and 1.3 percent of Zometa patients (p=0.13) experienced this adverse effect. In addition, Zometa-treated patients had increased rates of adverse events potentially associated with renal toxicity (2.6 percent higher) and increased rates of acute phase reactions (8.7 percent denosumab, 20.2 percent Zometa). As with previous studies in advanced cancer patients, hypocalcemia was more frequent in the denosumab arm (9.6 percent denosumab, 5.0 percent Zometa).

Patients received either 120 mg of denosumab subcutaneously every four weeks or Zometa administered intravenously as at least a 15 minute infusion at a dose of 4 mg every four weeks, per the labeled instructions.

Integrated Pain Analysis Shows Denosumab Superior to Zometa A separate integrated analysis of the three Phase 3 trials found that denosumab was superior to Zometa in preventing clinically relevant increases in pain, as reported by trial participants. Bone pain is one of the first s
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SOURCE Amgen
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