Amgen (Nasdaq: AMGN) today announced detailed results from a Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,046 patients with advanced breast cancer that met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. These results were presented today during the Presidential Session at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany (Abstract Number 2LBA).
Denosumab administered subcutaneously demonstrated superiority for both delaying the time to the first on-study skeletal related events (SREs) (fracture, radiation to bone, surgery to bone, or spinal cord compression) (hazard ratio 0.82, 95 percent CI: 0.71, 0.95), and delaying the time to first-and-subsequent SREs (hazard ratio 0.77, 95 percent CI:0.66, 0.89). Both results were statistically significant in this 34 month study. The median time to first on-study SRE was not reached for denosumab and therefore could not be estimated. The median time to first on-study SRE was 26.5 months for Zometa, the current standard of care.
"Up to 80 percent of patients with advanced breast cancer will develop bone metastases that are often associated with severe and painful bone complications, which are a serious concern for both patients and physicians," said Alison Stopeck, M.D., associate professor of Medicine, Arizona Cancer Center, University of Arizona Health Sciences Center, Tucson, AZ, United States of America. "Denosumab was superior to Zometa in preventing skeletal related events and delayed worsening of bone pain. In addition, denosumab also presented some potential tolerability advantages for many patients, including a lower incidence of renal toxicity and acute phase reactions, combined with the convenience of a monthly subcutaneous injection. Denosumab would be a welcome new treatment option for advanced breast cancer patients."
Denosumab also delayed the median time to first on-study SRE or hypercalcemia of malignancy (HCM) compared to Zometa (hazard ratio 0.82, 95 percent CI: 0.70, 0.95;>