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Denosumab superior to zoledronic acid in treatment of bone metastases in men with advanced prostate cancer, study shows
Tuesday, March 02 2010 | Comments
What's This?
Denosumab (Prolia; Amgen Inc.) significantly reduces skeletal-related events in men with advanced prostate cancer compared with zoledronic acid, according to new study results.The pivotal, double-blind, Phase III study included 1,901 patients who had bone metastases from hormone-refractory prostate cancer. The patients were randomized to receive denosumab 120 mg, administered subcutaneously every 4 weeks, or zoledronic acid 4 mg, administered intravenously as at least a 15-minute infusion every 4 weeks.
The primary endpoint was to assess whether denosumab was noninferior to zoledronic acid with respect to the first on-study skeletal-related event (fracture, radiation to bone, surgery to bone, or spinal cord compression). Secondary endpoints examined whether denosumab was superior to zoledronic acid with respect to the first on-study skeletal-related event, as well as first-and-subsequent on-study skeletal-related events. Other endpoints included safety, tolerability, overall survival, and time to disease progression.
Denosumab was shown to be noninferior to zoledronic acid with respect to the first on-study skeletal-related event.
Additionally, denosumab was superior to zoledronic acid in significantly delaying the time to the first on-study skeletal-related event by 18%, and it significantly reduced the rate of multiple skeletal-related events by 18% relative to zoledronic acid.
The 2 arms had similar overall rates of adverse and serious adverse events. Osteonecrosis of the jaw was reported in 22 patients in the denosumab arm and in 12 patients in the zoledronic acid arm, a between-group difference that was not statistically significant. Hypocalcemia was observed more frequently in the denosumab arm, consistent with previous studies of the agent in patients with advanced cancer, according to Amgen.
Overall survival and the time to cancer progression were balanced between the 2 treatment groups.
Amgen presented the results from 2 other late-stage pivotal trials of the biologic in September. Data from these 3 trials will form the basis for regulatory filings the company plans to submit later this year.
Full efficacy and safety data from this trial will be submitted for presentation at the American Society of Clinical Oncology meeting in June.
In October, Amgen received a complete response letter regarding its Biologics License Applications for denosumab as a preventive therapy and treatment for postmenopausal osteoporosis. In the letter, the FDA requested updated safety data and more information on Amgen's postmarketing surveillance program for the drug. The agency also wanted a new clinical program to support the prevention indication.
This information concerns a use that has not been approved by the Food and Drug Administration.
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