The Lancet Oncology Publishes Positive Phase 2 Results for XGEVA In Patients with Giant Cell Tumor Of Bone

Amgen

today announced the Lancet Oncology published planned interim results from an international, open-label, Phase 2 clinical trial that is evaluating XGEVA® (denosumab) in adults and skeletally mature adolescents diagnosed with giant cell tumor of bone (GCTB). The study's primary endpoint is the safety profile of XGEVA. Secondary endpoints are the time to disease progression and the proportion of patients without any surgery at six months. Based on the investigators' interim assessment, 96 percent (163/169) 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 percent (74/100) of patients required no surgery, and 62 percent (16/26) of patients who had surgery underwent a less morbid procedure than planned. Overall, 72 percent of patients had objective tumor response, per protocol defined criteria, including 25 percent of patients who had an objective tumor response according to modified RECIST(Response Evaluation Criteria In Solid Tumors). The overall safety profile was found to be consistent with the known safety profile of XGEVA in patients with advanced cancer. Osteonecrosis of the