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Amgen Reports Superior Efficacy For Denosumab Over Zometa In Bone Metastases Treatment Of Advanced Breast Cancer Patients - Update

Biotechnology company Amgen Inc. (AMGN) Tuesday said that a Phase 3, head-to-head trial evaluating denosumab in comparison with Zometa for the treatment of bone metastases in patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy.

Bone metastases is a second line cancer growth as a result of migration of cancer cells from primary tumors that settle on bone tissues. Bone metastases occur in more than 1.5 million people worldwide. Denosumab is the first fully human monoclonal antibody in late stage clinical development, the company stated.

According to the company, the trial was conducted in 2,046 patients with advanced breast cancer. Denosumab, administered subcutaneously demonstrated superiority for both delaying the time to the first on-study skeletal related events, or SREs, and delaying the time to first-and-subsequent SREs. Both results were statistically significant in the 34-month study. However, the median time to first on-study SRE was not reached for denosumab and therefore could not be estimated. The median time to first on-study SRE was 26.5 months for Zometa, the current standard of care, Amgen noted.

Amgen also said that denosumab delayed the median time to first on-study SRE or hypercalcemia of malignancy, or HCM, compared to Zometa. The median time to first on-study SRE or HCM was not reached for denosumab and therefore could not be estimated. The median time to first on-study SRE or HCM was 25.2 months for Zometa.

Further, the company said that in a pre-specified exploratory analysis, patients on the denosumab arm reported worsening of pain later than those on the Zometa arm. Overall survival and time to cancer progression were balanced between treatment arms. The incidence of adverse events and serious adverse events was consistent with what has previously been reported for these two agents. Adverse events potentially associated with renal toxicity occurred in 4.9% of patients treated with denosumab compared to 8.5% in patients treated with Zometa. Meanwhile, there was no statistically significant difference in the rate of Osteonecrosis of the jaw, or ONJ, between the two treatment arms, the company stated.

Commenting on the trial results, Alison Stopeck, associate professor of Medicine, Arizona Cancer Center, University of Arizona Health Sciences Center, Tucson, AZ, United States of America, stated, "In addition, denosumab also presented some potential tolerability advantages for many patients, including a lower incidence of renal toxicity and acute phase reactions, combined with the convenience of a monthly subcutaneous injection. Denosumab would be a welcome new treatment option for advanced breast cancer patients."

The trial results were presented today during the Presidential Session at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany.

The company also said that detailed data from another Phase 3, head-to-head trial evaluating denosumab versus Zometa was presented on Monday. This study involved 1,776 advanced cancer patients with solid tumors or multiple myeloma, and denosumab met its primary endpoint and demonstrated non-inferiority compared to Zometa in the treatment of bone metastases.

AMGN closed Monday's trading at $62.31, up $2.51, on a volume of 8.25 million shares.

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