Amgen’ phase-III trial evaluating denosumab versus Zometa (zoledronic acid) for bone metastases in 2,049 patients with advanced breast cancer, has met its primary and secondary endpoints. The trial also demonstrated superior efficacy compared to Zometa for denosumab.
Roger Perlmutter, Executive Vice President of R&D at Amgen, said: We are extremely pleased with the outcome of this important study, which shows that denosumab can reduce or delay the serious complications of bone metastases in breast cancer patients better than the current standard of care, and with a favorable benefit/risk profile.
These results underscore the importance of the RANK Ligand pathway in bone disease, and offer the promise of improved care for patients with advanced breast cancer. We look forward to reviewing the results from a second Phase 3 study of denosumab effects in advanced cancer patients later this year, he added.
Full efficacy and safety data will be submitted for presentation at an upcoming medical meeting in the second half of this year, said the company.