ARTICLE | Clinical News

Data for denosumab in giant cell tumor of bone

February 10, 2010 12:27 AM UTC

Researchers from the Peter MacCallum Cancer Centre and colleagues reported in Lancet Oncology that 120 mg subcutaneous denosumab from Amgen Inc. (NASDAQ:AMGN) every 28 days led to an 86% tumor response rate in a Phase II trial to treat giant cell tumor of bone. In 31 patients assessed for a clinical response, 26 reported clinical benefit, including reduced pain and improvements in function and mobility, and nine patients showed evidence of bone repair. The open-label, international trial enrolled 35 patients. Denosumab is a human mAb targeting receptor activator of NF-kappa B ligand ( RANKL; TNFSF11).

Amgen previously reported that denosumab met the primary endpoint of tumor response in 13 of 15 evaluable patients in the trial. The data were released after market close on Tuesday. Amgen was down $0.25 to $57.21 on the day. ...