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Denosumab Demonstrates Superiority Over Zometa(R) in Delay of Complications Due to Bone Metastases in Advanced Breast Cancer Patients
Date:9/22/2009

ersus Zometa was presented yesterday (Abstract #20LBA). In this study of 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma, denosumab met its primary endpoint and demonstrated non-inferiority compared to Zometa in the treatment of bone metastases.

Webcast Information

An analyst/investor event will also be held from the Congress on September 24th, at 6:30 a.m. Eastern Time 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 study comparing denosumab with Zometa in the treatment of bone metastases in patients with advanced breast cancer. Patients enrolled in the 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 in a 15 minute infusion every four weeks as per the label instructions.

In clinical trials testing new medications for bone metastases, treatment success has been measured by whether the bone complications, or SREs, caused by the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases studies use a composite endpoint of four SREs - fracture, the need for radiation to bone, the need for bone surgery, and spinal cord compression - to measure the effectiveness of denosumab versus Zometa.

The primary endpoint was to evaluate if denosumab is non-inferior to Zometa with respect to the first, on-study SRE in patients with advanced breast cancer and bone metastases. Secondary endpoints were to evaluate if denosumab was su
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