Amgen reports positive top-line results from XGEVA (Denosumab) Phase 3 trial for delay of bone complications in multiple myeloma patients

23rd October 2016 (Last Updated October 23rd, 2016 18:30)

Amgen has announced that a Phase 3 study evaluating XGEVA (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority in delaying the time to first on-study skeletal-related event (SRE) in patients suffering with multiple myeloma.

Amgen has announced that a Phase 3 study evaluating XGEVA (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority in delaying the time to first on-study skeletal-related event (SRE) in patients suffering with multiple myeloma.

The secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were, however, not met.

The hazard ratio of XGEVA versus zoledronic acid for overall survival was 0.90.

Multiple myeloma is the second most common hematologic cancer, which develops in plasma cells located within the bone marrow.

"Every year an estimated 114,000 new cases of multiple myeloma are diagnosed worldwide, leading to more than 80,000 deaths per year."

Every year an estimated 114,000 new cases of multiple myeloma are diagnosed worldwide, leading to more than 80,000 deaths per year.

The trial found that adverse events in patients treated with XGEVA were generally consistent with the known safety profile of XGEVA.

The common adverse events (greater than 25%) in the XGEVA arm of the study were diarrhea and nausea.

Amgen research and development executive vice-president Sean Harper said: "Bone complications like fracture, spinal cord compression and radiation or surgery to bone are devastating for multiple myeloma patients. Many of these patients suffer from renal impairment, which has limited their treatment options.

"XGEVA's unique mechanism of action has the potential to prevent bone complications in multiple myeloma patients regardless of their renal status, fulfilling an important unmet medical need."

The '482 study was an international, randomised, double-blind, multicentre trial of XGEVA compared with zoledronic acid in the prevention of bone complications in patients with newly diagnosed multiple myeloma.

A total of 1,718 patients (859 on each arm) were randomised for the study to receive either subcutaneous XGEVA 120mg and intravenous placebo every four weeks, or intravenous zoledronic acid 4mg (adjusted for renal function) and subcutaneous placebo every four weeks.