Amgen reports positive results from Phase II study of bone cancer drug

Interim results from the 12-month, open-label Phase II study show that 120mg of denosumab, administered subcutaneously once monthly with a loading dose at days 8 and 15 of month one, met the primary and all secondary endpoints. In this study, denosumab appeared generally well-tolerated.

The primary endpoint was tumor response (elimination of greater than or equal to 90% of giant cells or no radiographic progression of the target lesion). Out of 35 patients enrolled in the study, 25 were eligible for this interim analysis, with 24 receiving denosumab and 15 being eligible for efficacy analysis based on availability of pre- and post-radiology and histology assessments.

Approximately 13 of 15 patients (87%) had tumor response to denosumab treatment. Of those, nine of nine had a histologic response which showed almost complete or complete elimination of giant cells. In addition, four of six patients had a radiographic response demonstrating no further progression. The two patients who did not meet radiographic response criteria were considered stable by investigators. Three subjects reported evidence of new bone formation and repair visible by radiology.

David Thomas, department of haematology and medical oncology at Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia, said: “Denosumab has shown profound effect in this small group of subjects. For researchers in this field and our patients this represents an important advance in the understanding of potential treatment approaches for this rare disease.”