Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patient
August 03 2009 - 4:03PM
PR Newswire (US)
Second of Three Pivotal Phase Three Bone Metastases Trials Meets
Primary Endpoint Denosumab Delayed Time to Skeletal Related Events
THOUSAND OAKS, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Amgen
(NASDAQ: AMGN) today announced positive top-line results from a
pivotal Phase 3 head-to-head trial evaluating denosumab
administered subcutaneously versus Zometa (zoledronic acid)
administered as an intravenous (IV) infusion in the treatment of
bone metastases in 1,776 advanced cancer patients with solid tumors
(not including breast and prostate cancer) or multiple myeloma. For
the primary endpoint, patients treated with denosumab experienced a
similar time to first skeletal-related event (SRE) (fracture,
radiation to bone, surgery to bone, or spinal cord compression)
compared with those receiving Zometa (hazard ratio 0.84, 95 percent
CI: 0.71-0.98), which is statistically significant for
non-inferiority (p