Phase 3 trial of denosumab for bone metastases in hormone-refractory prostate cancer
Amgen announced results from its Phase 3, head-to-head trial that compared denosumab to Zometa (zoledronic acid, from Novartis) in 1,901 patients with bone metastases from hormone-refractory prostate cancer. The international, double-blind study randomized patients in a one-to-one ratio to receive either denosumab 120mg subcutaneously every four weeks or Zometa 4mg administered intravenously as at least a 15 minute infusion every four weeks as per the labeled instructions.
The primary and secondary endpoints used a composite endpoint of four skeletal related events (SREs) – fracture, radiation to bone, surgery to bone, and spinal cord compression – to measure the effectiveness. Study data demonstrated that denosumab was superior to Zometa in significantly delaying the time to first on-study SRE (p=0.008), the primary endpoint, with a median time to first on-study SRE of 20.7 months versus 17.1 months for Zometa. The secondary endpoint also showed denosumab to be superior to Zometa in significantly delaying the development of multiple SREs (time to first and subsequent on-study SRE) (p=0.004).
Denosumab is an investigational fully human monoclonal antibody in late stage clinical development that specifically targets the RANK Ligand, the essential regulator of osteoclasts.
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