Preliminary phase III clinical trial results show that Amgen’s XGEVA (Denosumab) is as effective as the current gold standard zoledronic acid in preventing bone disease complications in patients with multiple myeloma (a type of bone marrow cancer).
Multiple myeloma is a type of cancer that affects plasma cells. Plasma cells are white blood cells that are located predominantly in bone marrow and produce antibodies needed to fight infections. When cancerous or abnormal plasma cells accumulate in the bone marrow, bone damage occurs that can lead to bone pain, fractures, bone surgery, pressure on the spinal cord, or need for bone radiation. Every year, over 110,000 cases of multiple myeloma are diagnosed globally, and 75% of these patients are treated for the prevention of bone complications. The prevention of serious bone complications is critical for multiple myeloma patients as it contributes to increased morbidity.
Amgen is a well-known biotechnology company that develops therapies for diseases with unmet need, which has an oncology branch that focuses solely on therapies for malignancies. Recent results from an international phase III clinical trial comparing the safety and efficacy of Amgen’s drug XGEVA (denosumab), which inhibits molecules that break down bone, to the current gold standard therapy zoledronic acid has shown promising results in patients newly diagnosed with multiple myeloma.
The study involved approximately 1700 patients who were randomly given either XGEVA or zoledronic acid every four weeks. Their primary finding was that XGEVA was as efficacious as zoledronic acid in delaying the time to a patient’s first bone or skeletal-related event. The overall survival of XGEVA to zoledronic acid was estimated at 0.90 with an error of ~0.2, indicating that the survival rate of patients were equal when either drug was used. Common adverse effects for patients treated with XGEVA were diarrhea and nausea, both of which were consistent with its known safety profile.
The comparative efficacy of XGEVA and zoledronic acid shows that XGEVA, a marketed drug indicated for other bone health issues, has great potential as an alternative and effective therapy to prevent bone complications in patients with multiple myeloma. It will be exciting to see what other results arise from this study when it officially concludes in mid-2019.
Written By: Fiona Wong, PhD