Amgen Presents New XGEVA™ (Denosumab) Breast Cancer Skeletal-Related Event Prevention Dat... (I 0.71 0.95) p 0.0096 (superiority...)

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Amgen Presents New XGEVA™ (Denosumab) Breast Cancer Skeletal-Related Event Prevention Data at SABCS

Date:12/10/2010

I 0.71, 0.95), p= 0.0096 (superiority). Additionally, continued XGEVA treatment significantly reduced the proportion of patients who experienced pathologic fractures or radiation to bone compared with Zometa.

Overall survival and disease progression were similar for both treatment groups and a similar percentage of patients reported adverse events and serious adverse events. Osteonecrosis of the jaw was reported in 2.5 percent of XGEVA patients and 1.8 percent of Zometa patients, while hypocalcemia was reported in 6.1 percent of XGEVA treated patients and 3.7 Zometa treated patients.

"These results reinforce the superior efficacy profile of XGEVA versus Zometa and provide us additional reassurance of this important new product's safety profile," said Allison Stopeck M.D. associate professor of Medicine, Arizona Cancer Center, University of Arizona Health Sciences Center, Tucson, Ariz. "I feel confident that XGEVA can provide patients with advanced breast cancer that have developed a bone metastases an excellent option to prevent debilitating and costly bone complications."

Patients Receiving XGEVA Experienced Less Pain, and Report Pain Interfered Less with Daily Functioning, Compared to Patients Receiving Zometa (Abstract Number: P1-13-01)Bone pain is one of the first signs that metastatic disease has spread to the bone, and affects approximately 70 percent of patients with metastatic disease(i), and nearly 80 percent of patients with advanced breast cancer.(ii) A new analysis of study "136" data showed that those patients treated with XGEVA experienced less pain-related interference with their daily functioning than those receiving Zometa.

The analysis, presented yesterday, was based on a patient completed Brief Pain Inventory (BPI). Results demonstrated that patients on XGEVA tended to experience a reduction in pain interference with their daily functioning compared to those on Zometa (n=1124; median: 70 days XGEVA vs.
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