Denosumab: Additional Phase II data

Researchers at the Peter MacCallum Cancer Centre and colleagues reported additional data from an open-label, international Phase II trial in 35 patients showing that 120 mg subcutaneous denosumab every 28 days led to an 86% tumor response rate. In 31 patients assessed for a clinical response, 26 reported clinical benefit, including reduced pain and improvements in function and mobility, and 9 patients showed evidence of bone repair. The most common adverse events were pain in an extremity, back pain and headache. Data were published in the Lancet Oncology. Amgen previously reported that denosumab met the primary endpoint of tumor response in 13 of 15 evaluable patients in the trial (see BioCentury, June 9, 2008). ...