Amgen offers promising Xgeva data on bone metastasis, pain

Already buoyed by the initial success of Xgeva, Amgen today unveiled new data at the annual meeting of the American Urological Association that helps build its case for the treatment. The company hopes to counter some of the doubts that arose late last year when researchers announced the drug had delayed the spread of prostate cancer to the bones, but didn't offer evidence of a survival advantage.

According to researchers, patients taking the drug were able to extend their stage of bone metastasis-free survival by a median of 4.2 months compared with placebo. And combined with other new and late-stage drugs for advanced prostate cancer, the big biotech hopes Xgeva will help push this disease toward the category of a more manageable, chronic disease rather than a death sentence. In the process, analysts have estimated that Amgen could earn up to a billion dollars a year more if Xgeva is approved for use in delaying bone metastasis.

In less than a year new drugs like Dendreon's Provenge and J&J's newly approved abiraterone have given castration-resistant prostate cancer victims some fresh options that can help stave off death. And Amgen's Roy Baynes, the VP of clinical development, says researchers have now demonstrated in Phase III that Xgeva can fit into a phase before a case advances to a late stage, when telltale biomarkers signal that the cancer appears ready to spread.

"Each one of these (new drugs) is making an incremental advance. It gets back to the chronic disease concept," Baynes tells FiercePharma, where new drugs can "add a period of time" for patients, collectively stretching out the survival stage for patients with the most aggressive types of the disease.

This is the first large randomized study to demonstrate bone metastasis prevention in men with CRPC, says Baynes, after a number of failures were reported in recent years. Initially approved to treat osteoporosis, Amgen has been following up with a big round of new Phase III trials to extend its blockbuster market potential for its denosumab franchises. During the first quarter, Amgen impressed analysts with $42 million in revenue for Xgeva, outpacing income for Prolia, which uses a different dose of denosumab.

The prostate cancer field has been a key target of a number of developers. Medivation has attracted attention for its work on the promising late-stage MDV3100, another treatment that is likely to be pitted against abiraterone for CRPC. And further back in the clinic is Aragon Pharmaceuticals' ARN-509, which has been spotlighted as a key next-gen treatment for hormonally driven cancer.

- here's the story from Reuters

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