Amgen has announced interim data from a Phase II clinical study of denosumab, an investigational fully human monoclonal antibody that inhibits RANK Ligand. Denosumab treatment resulted in a rapid suppression of bone turnover among advanced cancer patients with bone metastases; these results were also sustained at all time points measured in the study.
Interim results from an ongoing study of 255 IV bisphosphonate-naive breast cancer patients with established bone metastases, evaluating different doses of denosumab administered monthly or every three months, were presented in an oral session this morning. Urinary N-telopeptide levels, a biomarker for bone turnover, are increased by metastatic bone disease. Researchers reported that at study week 13, there was a median decrease in urinary N-telopeptide for each denosumab treatment cohort ranging from 63 percent to 82 percent. Based on the dose responses, a Phase III trial will evaluate 120 mg dosed monthly.