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Can 'double blockbuster' strengthen Amgen's backbone?

Nature Biotechnology volume 26, pages 361–362 (2008)Cite this article

An Erratum to this article was published on 01 August 2008

The company has now got what it needed: in late January, it reported that in a nonpivotal, comparative phase 3 study, denosumab can lead to a relative improvement in bone mineral density (BMD) of up to 40% compared with alendronate. That backs up good news from December, when Amgen released data from a pivotal, placebo-controlled phase 3 study indicating that the mAb also increased BMD in nonmetastatic breast cancer patients on aromatase inhibitor therapy.

Before regulatory approval in osteoporosis, however, Amgen still faces several hurdles. It must demonstrate that the effects on BMD translate into more clinically meaningful reductions in fracture risk. So denosumab's future in the osteoporosis indication hinges on the outcome of a 7,700-patient pivotal trial, the primary endpoint of which is reduction in vertebral fracture over three years. The study also measures two secondary endpoints: reduction in nonvertebral fracture—humerus, hip and radius data combined—and reduction in hip fracture alone because of its association with morbidity and mortality among elderly patients. Its impact on those secondary endpoints will have a major influence on its competitive standing.

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    Cormac Sheridan

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Sheridan, C. Can 'double blockbuster' strengthen Amgen's backbone?. Nat Biotechnol 26, 361–362 (2008). https://doi.org/10.1038/nbt0408-361

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