Phase 3 Trial Shows Denosumab Delayed Skeletal Related Events in Advanced Cancer Patients With Bone ...(u-like symptoms associated with Zometa a...),Health

Bone metastases, the spread of tumors to the bone, are a serious concern for many advanced cancer patients. When cancer spreads to the bone, the growing cancer cells weaken and destroy the bone around the tumor. This damage can result in a number of serious bone complications, collectively called skeletal related events.

Denosumab also delayed the median time to first on-study SRE or hypercalcemia of malignancy (HCM) compared to Zometa (hazard ratio 0.83, 95 percent CI: 0.71, 0.97; p=0.02). The median time to first on-study SRE or HCM was 19.0 months for denosumab and 14.4 months for Zometa.

Bone destruction is a major cause of pain in approximately 70 percent of patients with metastatic disease. (1) In an exploratory analysis, patients on the denosumab arm reported worsening of pain later than those on the Zometa arm (57 days versus 36 days, respectively).

Adverse events rates (96 percent denosumab, 96 percent Zometa) and serious adverse events (63 percent denosumab, 66 percent Zometa) were similar between groups and were 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 (hazard ratio 0.95, 95 percent CI: 0.83-1.08; p=0.43) and the time to cancer progression (hazard ratio 1.00, 95 percent CI: 0.89, 1.12; p=1.0).

Detailed data from a second Phase 3, head-to-head trial evaluating denosumab versus Zometa will be presented Tuesday, Sept. 22, 2009 at 14:15 - 14:30 Central European Summer Time (CEST) in the Presidential Session of ECCO-ESMO (Abstract #2L
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