giant cell tumour of bone

Biotechnology company Amgen has reported planned interim safety and efficacy results from Phase II trial of a fully human monoclonal antibody, Xgeva (denosumab), in patients with giant cell tumour of bone (GCTB).

The interim assessment of the international, open-label trial observed no disease progression after a median follow-up of 13 months in 96% (163/169) of patients with surgically unsalvageable GCTB.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Around 74% (74/100) of patients with salvageable GCTB whose surgery was associated with severe morbidity required no surgery, where as 62% (16/26) of patients who had surgery underwent a less morbid procedure than intended.

Objective tumour response was noted in 72% of patients, as per protocol defined criteria, including 25% of patients who had an objective tumour response as assessed by modified Response Evaluation Criteria In Solid Tumors.

Amgen research and development executive vice-president Sean Harper said the results indicate Xgeva’s effectiveness in treating GCTB and its understanding of the rare disease in which RANK Ligand plays an essential role.

"XGEVA represents a much needed treatment option for patients who suffer from giant cell tumor of bone that can’t be adequately treated with surgery."

"XGEVA represents a much needed treatment option for patients who suffer from giant cell tumor of bone that can’t be adequately treated with surgery," Harper said.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

A consistent overall safety profile with that of known safety profile of XGEVA in patients with advanced cancer was also noted.

Low phosphate levels, back pain, extreme pain, depression, musculoskeletal pain and anaemia were the most common severe adverse events, while the serious adverse events were reported in 9% of patients.

The primary end point of the study, which involved adults and skeletally mature adolescents, is the safety profile of Xgeva.

Secondary endpoints include the time to disease progression and the proportion of patients without any surgery at six months.

Image: High magnification micrograph of a giant cell tumour of bone, also giant cell tumour of bone. Photo: courtesy of Nephron.