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Phase 3 Trial Shows Denosumab Delayed Skeletal Related Events in Advanced Cancer Patients With Bone Metastases
Date:9/21/2009

BA; presentation embargoed until 12:15 CEST Sept. 22, 2009). In this study of 2,049 patients with advanced breast cancer, denosumab met all primary and secondary endpoints and demonstrated superior efficacy compared to Zometa in the treatment of bone metastases.

Webcast Information

Denosumab data presented at ECCO-ESMO today will be discussed by Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen at the UBS Global Life Sciences Conference in New York this morning at 8:30 a.m. Eastern Time (ET). Live audio of the presentation will be available over the Internet and can be accessed from Amgen's Web site at www.amgen.com, under Investors.

An analyst/investor event will also be held from the Congress on September 24th, at 6:30 a.m. ET to discuss data presented at ECCO-ESMO. A webcast of the event can be found on Amgen's Web site at www.amgen.com, under Investors. The audio webcast will be archived and available for replay for at least 72 hours.

Study Design

This was an international, Phase 3, randomized, double-blind, active-comparator-controlled study comparing denosumab with Zometa in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. Patients enrolled in this event-driven study were randomized in a one-to-one ratio to receive either 120 mg of denosumab subcutaneously every four weeks (Q4W) or Zometa administered intravenously at a dose of 4 mg delivered as a single, 15-minute infusion every four weeks.

In clinical trials thus far to test new medications for bone metastases, treatment success has been measured by whether the bone complications, or SREs, caused by the tumor a
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SOURCE Amgen
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