Prolia denosumab: Additional Phase III data

Additional data from a double-blind, head to head, international Phase III trial in 2,049 advanced breast cancer patients showed that the median time to the first on-study SRE had not yet been reached for subcutaneous denosumab vs. 26.5 months for IV Zometa zoledronic acid. Denosumab also delayed the time to first on-study SRE or hypercalcemia of malignancy vs. Zometa (not yet reached vs. 25.2 months, p=0.007). Data were presented at the joint European CanCer Organisation and European Society for Medical Oncology meeting in Berlin.

Amgen previously reported that denosumab was superior to Zometa on the primary endpoint of time to the first on-study SRE and on the secondary endpoint of time to the first and subsequent on-study SREs (see BioCentury, July 13). ...