Amgen has announced the primary results from a Phase III trial of Xgeva (denosumab), which prevents the spread of cancer to the bone in men with advanced prostate cancer.
The randomised, placebo-controlled, multicentre Phase III study included 1,432 men with hormone-refractory prostate cancer and showed that the drug increased bone metastasis-free survival for more than four months, delayed the time to first bone metastasis and reduced risk by 15% compared with the placebo.
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Massachusetts General Hospital Cancer Center’s Boston Genitourinary Malignancies Programme director Matthew Smith said Xgeva is the first and only bone-targeted therapy that has demonstrated the ability to reduce the risk of bone metastasis in men with prostate cancer.
Xgeva is a fully human monoclonal antibody that prevents rank ligand from activating its receptor, thereby decreasing bone destruction.
The adverse affects observed with increased frequencies in the Xgeva-treated patients include back pain, hypocalcemia and osteonecrosis of the jaw.
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