Amgen announces positive denosumab phase III trial

Amgen has announced positive top-line results from a phase III trial into denosumab compared to Zometa (zoledronic acid).

The study saw the former administered subcutaneously, while the latter was delivered as an intravenous infusion for the treatment of bone metastases in advanced cancer patients with solid tumours or multiple myeloma.

Bone metastases involve the spread of tumours to the bone and Amgen noted that these are a “serious concern” for many patients with advanced cancer. The damage can result in a range of serious bone complications.

In the study, it was found that osteonecrosis of the jaw rates were balanced and infrequent in both treatment conditions, while overall survival rate and time to cancer progression were both balanced between the two treatment arms.

“We are very encouraged by the overall strength of the data, which we will present in a scientific forum later this year,” said executive vice-president of research and development at Amgen Roger Perlmutter.

He added: “We are also looking forward to reviewing the results of a final skeletal-related event study, in patients with advanced prostate cancer, next year.”

Last month, Amgen announced plans to work with GlaxoSmithKline to commercialise denosumab in Europe for postmenopausal osteoporosis.