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October 30, 2007 NEW YORK (Reuters Health) - The experimental drug denosumab seems to work at least as well as bisphosphonate therapy in limiting bone turnover in patients with breast cancer metastatic to bone, according to results of a randomized active-controlled phase II study. The fully human monoclonal antibody denosumab inhibits bone resorption by binding and neutralizing the pro-osteoclast ligand RANKL. It is being developed by Amgen Inc., which funded the current study appearing in the Journal of Clinical Oncology for October 1st. Dr. Allan Lipton of the Milton S. Hershey Medical Center, Pennsylvania, and colleagues studied 255 women with breast cancer-related bone metastases not previously treated with intravenous bisphosphonates. They were randomly assigned to IV bisphosphonate therapy or to one of five denosumab arms (30, 120 or 180 mg administered subcutaneously every 4 weeks, or 60 or 180 mg administered every 12 weeks). For the pooled denosumab groups, the researchers saw a median reduction of 71% from baseline to week 13 in the bone turnover marker, urine N-telopeptide corrected for urine creatinine (uNTx/Cr). The median reduction in this bone turnover marker in the bisphosphonate arm was 79%. Overall, 74% of denosumab-treated patients (157 of 211) saw a greater than 65% reduction in uNTx/Cr compared with 63% of bisphosphonate-treated patients (27 of 43). Nine percent of denosumab-treated patients experienced skeletal-related side effects during the study versus 16% of bisphosphonate-treated patients; no serious or fatal adverse events related to denosumab occurred. These data suggest that subcutaneous denosumab "may be similar to IV bisphosphonates in suppressing bone turnover" with a safety profile "consistent with an advanced breast cancer population receiving systemic therapy." "Phase III trials evaluating the efficacy of denosumab in preventing and treating complications caused by bone metastases are in progress," Dr. Lipton and colleagues note. Copyright 2008 Reuters. Click for Restrictions.
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