Denosumab is a fully human monoclonal antibody specific for the RANK ligand, which is essential for the differentiation, function and survival of osteoclasts. Denosumab is already licensed as Prolia to treat bone loss in postmenopausal women and in men with prostate cancer.
Three randomised, double-blind studies assessed the capacity of denosumab, given as a 120mg subcutaneous injection every four weeks, to prevent events such as pathological fracture and spinal cord compression in 5723 patients with advanced malignancies. The studies enrolled patients with breast cancer, prostate cancer, and other solid tumours or multiple myeloma.
Compared with zoledronic acid, denosumab increased the median time to the first skeletal-related event by 8.2 months (from 19.4 months to 27.6 months; p<0.0001). Overall survival and time to pain improvement were similar for the two agents.
Further Information: Amgen