At the recent American Society of Clinical Oncology (ASCO) conference, Amgen presented data from a Phase III study showing that their drug XGEVA® (Denosumab) had equal benefit as Zometa (zoledronic acid) with fewer kidney side effects.
The news is a good one for patients who may already have compromised kidneys as a result of their multiple myeloma. Bone strengtheners are common drugs administered to myeloma patients who have bone damage caused by myeloma. The paper was selected as one of the “Best of ASCO Educational Program.”
The Phase III study included 1718 patients and is the largest myeloma study of its kind. Study results showed that both denosumab and zoledronic acid showed similar results for time to future skeletal events, the primary end point.
Patients on the denosumab arm had a significantly lower rate of renal adverse events compared to zoledronic acid (10% vs. 17.1%)
In patients with renal insufficiency (creatine clearance of less than 60 mL/min), the rate of renal adverse events was doubled in the zoledronic acid arm (26.4%) vs. the denosumab arm (12.9%). The study excluded patients who had a creatine clearance of less than 30 mL/min.
“Bone complications in multiple myeloma patients, including fractures, can have a devastating impact on patients. Current treatment options for these complications are limited to bisphosphonates, including zoledronic acid, which are cleared by the kidneys and can be associated with increased renal toxicity,” said Noopur Raje, M.D., director, Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston. “Renal impairment is a common complication in multiple myeloma patients. Denosumab, which is not cleared by the kidneys, may offer a novel, safe and effective option for multiple myeloma patients.”
XGEVA is currently used to prevent fractures and other skeletal-related events in patients with bone metastases from solid tumors and is the number one prescribed agent for this indication in the United States. It is not currently approved for multiple myeloma patients. Amgen submitted their FDA application in April of 2017 to expand the approval into myeloma.
“Preventing fractures and other bone complications and preserving renal function are two of the most important aspects to consider when caring for patients with multiple myeloma,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Up to 40 percent of patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis, underscoring the need for alternative treatment options. We look forward to making XGEVA, a novel treatment option, available to multiple myeloma patients.”