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news.Amgen's XGEVA improved median bone metastasis-free survival by 4.2 months compared to placebo (primary endpoint), and improved time to first occurrence of bone metastases (secondary endpoint) in a randomised, placebo-controlled, multi-center '147 study Phase 3 trial.
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Amgen has evaluated XGEVA (denosumab) versus placebo in 1,432 men with castrate-resistant prostate cancer in ‘147 study Phase 3 trial.
In the trial, the overall survival was similar between the XGEVA and placebo groups (secondary endpoint).
Amgen claims that XGEVA is a fully human monoclonal antibody that binds to RANK Ligand.
XGEVA prevents RANK Ligand fromactivating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction and halting release of growth factors, making the environment less conducive to tumor growth.
Amgen Research and Development executive vice president Roger Perlmutter said that their data demonstrate that XGEVA, which antagonises the RANK Ligand axis, limits the ability of tumors to colonize bone, an important finding for men at risk for bone metastases and their healthcare providers.