Integrated Analysis Demonstrates That Denosumab Delays the Onset of Bone Complications Compared to Zometa®

Sun, 10/10/2010 - 3:31am

THOUSAND OAKS, Calif., Oct. 10 /PRNewswire-FirstCall/ -- Amgen (Nasdaq:  AMGN) today announced results from two integrated analyses of head-to-head pivotal Phase 3 trials comparing denosumab to Zometa® (zoledronic acid), the current standard of care in the prevention of skeletal related events (SREs) in patients with advanced malignancies involving bone. In these separate analyses, denosumab demonstrated a clinically meaningful, consistent and robust treatment effect across tumor types in the reduction of SREs, and also prevented clinically relevant increases in pain, compared with Zometa. A separate presentation highlighted the meaningful burden that SREs pose to the healthcare system. These analyses were presented at the 35th European Society for Medical Oncology (ESMO) Congress being held in Milan, Italy.

"Bone metastases and their subsequent complications, such as a fracture, are devastating events for advanced cancer patients and costly to the healthcare system," said Allan Lipton, M.D., professor of Medicine & Oncology, M.S. Hershey Medical Center of the Pennsylvania State University. "This analysis of the largest registration program ever undertaken in bone metastases demonstrates that denosumab can offer a clinical advance over Zometa in delaying or preventing these bony complications, as well as the pain that frequently results from them. These efficacy gains coupled with the convenience of a subcutaneous injection and no need for renal monitoring make denosumab an attractive option for these patients."

Integrated Analysis Reveals Denosumab Superior to Zometa In Delaying or Preventing Time to First-and-Subsequent Skeletal Related Event Across a Broad Cancer Population with Bone MetastasesThe effect of denosumab versus Zometa was evaluated in three large, identically designed Phase 3 trials that enrolled patients with bone metastases and breast cancer, prostate cancer or other solid tumors and multiple myeloma. The integrat





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