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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