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.
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," Harper said.
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.