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Amgen Says Denosumab Delayed Skeletal Related Events In Cancer Patients - Update

Monday, biotechnology company Amgen (AMGN) said that results from a late-stage trial of denosumab in advanced cancer patients with bone metastases showed that the drug delayed skeletal related events such as fracture, radiation to bone, surgery to bone, or spinal cord compression.

The phase 3 trial compared denosumab administered subcutaneously with FDA approved Zometa, or zoledronic acid, administered as an intravenous infusion to treat bone metastases in 1,776 advanced cancer patients with solid tumors. The trial did not include patients with breast and prostate cancer or multiple myeloma.

The trial's primary endpoint was to evaluate if denosumab is non-inferior to Zometa with respect to the first on-study skeletal related event, or SRE, in patients with advanced cancer or multiple myeloma. Secondary endpoints were to evaluate if denosumab is superior to Zometa with respect to the first on-study SRE as well as first-and-subsequent on-study SREs, and to assess the safety and tolerability of denosumab compared with Zometa.

For the primary endpoint of this study, the median time to first on-study SRE was 20.6 months for patients receiving denosumab and 16.3 months for patients receiving Zometa.

The company noted that although numerically greater, the delay in the time to first SRE associated with denosumab was not statistically superior compared to Zometa based upon the statistical testing strategy, although it was numerically greater. The time to first-and-subsequent SRE was also numerically greater, but not statistically superior compared to Zometa.

According to David Henry, M.D., clinical professor of Medicine, Pennsylvania Hospital, Philadelphia, "It is encouraging to see denosumab's efficacy in this broad cancer population. There is no need for renal monitoring or dose adjustments due to renal impairment."

He added that the positive results of this study, combined with the convenience of a monthly subcutaneous injection and without the flu-like symptoms associated with Zometa administration, make this an exciting potential treatment option for advanced cancer patients.

Adverse and serious adverse events rates were similar between both groups and were consistent with what has previously been reported for these two agents.

The company intends to present detailed data from a second Phase 3, head-to-head trial evaluating denosumab versus Zometa will on September 22. In this study of 2,049 patients with advanced breast cancer, denosumab met all primary and secondary endpoints and demonstrated superior efficacy compared to Zometa in the treatment of bone metastases.

According to Amgen, denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts or the cells that break down bone. With more than 19,000 patients in trials across indications worldwide, the denosumab development program is the largest ever initiated by Amgen.

AMGN is currently trading on Nasdaq at $61.73, up 1.56% .

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