Summary
Metastatic spread to the bone is a common and problematic complication for many patients with advanced cancer. Current treatment with bisphosphonates only modestly controls skeletal spread. This study suggests that the monoclonal antibody Denosumab has biologic and clinical activity to help patients who are at risk for further bone metastases despite bisphosphonate therapy.
Analysis
Although this Phase II study is complicated in design, and set up a 'straw man' as the active control, it still looks like Denosumab is a potentially viable and reasonable alternative when patients are at risk for progression on bisphosphonates.
Denosumab is being developed by Amgen. An approval for Denosumab for any setting of metastatic cancer to the bone - especially for prostate - will likely take a bite out of the share being delivered by Novartis' bisphosphonate Zometa.
