Phase II study of Xgeva (Amgen) for Giant Cell Tumour of Bone published in Lancet Oncology

Interim results from an international, open-label, Phase II clinical trial evaluating Xgeva (denosumab), from Amgen, in adults and skeletally mature adolescents diagnosed with Giant Cell Tumor of Bone (GCTB), show that 96% of patients with surgically unsalvageable GCTB had no disease progression after a median follow-up of 13 months. In those with salvageable GCTB whose surgery was associated with severe morbidity, 74% of patients required no surgery, and 62% of patients who had surgery underwent a less morbid procedure than planned. Overall, 72% of patients had objective tumor response, per protocol defined criteria, including 25% of patients who had an objective tumor response according to modified Response Evaluation Criteria In Solid Tumors.

The overall safety profile was found to be consistent with the known safety profile of the drug. Osteonecrosis of the jaw was reported in 1% of patients. Hypocalcemia adverse events, all non-serious, were reported in 5% of patients. The most common severe adverse events were low phosphate levels, back pain, pain in extremity, depression, musculoskeletal pain and anemia. Results were published in Lancet Oncology: "Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study." Dr Sant Chawla MD et al. Lancet Oncology, July 16, 2013 doi:10.1016/S1470-2045(13)70277-8