Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.A phase 3 study assessing Amgen’s Xgeva (denosumab) compared to zoledronic acid (ZA) for the prevention of bone complications in newly diagnosed multiple myeloma (MM) patients met its primary endpoint.
Subscribe to our email newsletter
In the '482 study, a total of 1,718 patients were randomized to receive either subcutaneous XGEVA 120 mg and intravenous placebo every four weeks, or intravenous zoledronic acid 4 mg (adjusted for renal function) and subcutaneous placebo every four weeks.
The primary endpoint was a non-inferiority test defined by the time to the first skeletal-related event (SRE).
The study, however, did not meet the secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE.
Amgen said the hazard ratio of Xgeva versus zoledronic acid for overall survival was 0.90 (95 percent CI, 0.70 – 1.16).
Amgen executive vice president of research and development Sean Harper said: "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."
Xgeva targets the RANK ligand pathway to avoid the formation, function and survival of osteoclasts, which break down bone.
It is indicated to prevent SREs in patients with bone metastases from solid tumors and treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
In the US, Xgeva is also indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. It is not indicated to prevent SREs in patients with multiple myeloma.