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Bone Metastases

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October 3, 2011

Bayer Healthcare issued results from a phase III trial of radium-223 chloride for castration-resistant prostate cancer and symptomatic bone metastases. This double-blind, randomized, controlled study, dubbed ALSYMPCA (ALpharadin in SYMptomatic Prostate Cancer), enrolled 922 subjects with advanced, hormone-refractory prostate cancer that had metastasized to the skeleton. The subjects received Alpharadin plus best standard of care or placebo plus best standard of care. The primary endpoint was overall survival. The overall survival result was statistically significant, with a median overall survival of 14 months for radium-223 chloride and 11.2 months for placebo (p≡0.0022). The time to first skeletal related events was 13.6 months versus 8.4 months, a 64% improvement (p≡0.00046). Total alkaline phosphatase normalization was reached by 33% versus 1% of subjects (p<0.001) and radium-223 chloride resulted in a 49% improvement in time to prostate-specific antigen progression (p≡0.00015).

February 15, 2010

Amgen reported positive results from a phase III study of denosumab for bone metastases resulting from prostate cancer. This international, head-to-head, randomized, double-blind study enrolled 1,901 men with bone metastases from hormone-refractory prostate cancer. The subjects received either 120 mg of denosumab subcutaneously every four weeks or 4 mg Zometa (standard of care) intravenously as a 15 minute infusion every four weeks. The primary endpoint was to determine if denosumab is non-inferior to Zometa with respect to the first on-study skeletal-related event (SRE's). The composite endpoint of four SREs- fracture, radiation to bone, surgery to bone, and spinal cord compression- was used to measure the effectiveness of denosumab versus Zometa. Denosumab demonstrated superiority over Zometa for both delaying the time to the first on-study SRE and reducing the rate of multiple SREs. Overall rates of adverse events and serious adverse events, including infections, were generally similar between the two arms.

August 10, 2009

Amgen issued positive results from a phase III trial of denosumab for the treatment of bone metastases due to solid tumors or multiple myeloma. This international, randomized, double-blind, active controlled study enrolled 1,776 subjects with advanced cancer. The subjects received either 120 mg of denosumab subcutaneously every four weeks (Q4W) or Zometa administered intravenously at a dose of 4 mg single, 15 minute infusion every four weeks. The primary endpoint was to evaluate if denosumab is non-inferior to Zometa with respect to the first on-study skeletal related event (SRE), measured using a composite endpoint of four SREs: fracture, radiation to bone, surgery to bone, or spinal cord compression. The subjects treated with denosumab experienced a similar time to first SRE 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). The delay in the time to first SRE, although numerically greater in the denosumab treatment arm, was not statistically superior compared to Zometa (adjusted p≡0.06). The time to first-and-subsequent SRE was also numerically greater but not statistically superior compared to Zometa. Treatment was well tolerated.

July 13, 2009

Amgen released positive results from a phase III trial of denosumab for the treatment of bone metastases due to breast cancer. This international, randomized, double-blind study enrolled 2,049 female subjects with advanced breast cancer and bone metastases. The subjects were randomized to receive either 120 mg of denosumab subcutaneously every four weeks (Q4W) or Zometa administered intravenously at a dose of 4 mg single, 15 minute infusions every four weeks. The primary endpoint was to evaluate if denosumab is non-inferior to Zometa with respect to the first on-study Skeletal Related Events (SREs). Superiority was demonstrated with statistical significance for both delaying the time to the first on-study SREs (fracture, radiation to bone, surgery to bone, or spinal cord compression) and delaying the time to the first-and-subsequent SREs. There were no unexpected adverse events or serious adverse events. Overall survival and the time to cancer progression were similar between the treatment arms.

October 21, 2002

Novartis reported positive results from a study to examine the long-term efficacy of Zometa. Novartis submitted the data along with its sNDA for the indication of bone metastases developed from advanced cancers. The data was analyzed from three large multi-center, randomized pivotal trials of more than 3,000 patients The trials demonstrate that the benefits of Zometa were maintained over the approximately two years of treatment follow-up. In addition, breast cancer patients treated with Zometa 4 mg had a significantly lower risk of developing skeletal complications after two years of treatment, compared with those treated with pamidronate 90 mg.