Xgeva (denosumab), marketed by Amgen, works to prevent bone-related complications in patients with solid tumors that have spread to the bone. A monoclonal antibody, the therapy helps cancer patients avoid fractures and other serious bone complications by targeting a protein involved in the buildup and breakdown of bone.
How Xgeva works
Bones in a healthy person are continuously being remodeled to maintain their health and strength. This is done by osteoclasts, cells that break down bone, and osteoblasts, cells that build new bone. A balance between the activity of osteoclasts and osteoblasts is essential for bone health and typically exists.
But cancer that spreads to the bone disrupts this balance, as osteoclasts become more active than osteoblasts. This leads to a net breakdown of bone, and weaker bones are prone to fractures.
Xgeva works to strengthen bone by binding to a protein called RANKL, which controls the activity of osteoclasts. The binding of Xgeva to RANKL slows their activity to lessen the speed by which bones break down, helping to keep bones stronger.
Xgeva in clinical trials
Several clinical studies support the efficacy of Xgeva in preventing these bone-related complications of cancer: fractures, spinal cord compressions, the need for radiation to treat metastasis to the bone, and the need for surgery to repair or strengthen broken bones.
The studies compared the efficacy of Xgeva to zoledronic acid to prevent bone complications in patients who had bone metastases from solid tumors. One involved women with breast cancer, a second involved prostate cancer patients, and a third in patients with solid tumors other than breast and prostate cancer, including patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
An analysis of the combined data from these three trials found that the first serious bone event occurred approximately 8.2 months later in patients treated with Xgeva compared to patients treated with zoledronic acid. The benefits of bone-targeted therapies in delaying bone complications and improving quality of life specifically in lung cancer patients with bone metastases have also been studied.
In April 2017, Amgen announced results from a Phase 3 study involving patients newly diagnosed with multiple myeloma. Results found little difference in delayed complications (delayed time to first bone event) between Xgeva-treated patients and those given zoledronic acid, but Xgeva use resulted fewer kidney problems, which is important in multiple myeloma, as these patients are more likely to have kidney damage. Although the results were encouraging, Xgeva is not currently indicated for patients with multiple myeloma.
Xgeva is injected under the skin usually in the upper arm, upper thigh, or abdomen, once every four weeks. Because it can lower blood calcium levels, patients with low calcium levels should inform their doctor before starting Xgeva. The treatment can harm unborn babies and should be used with caution in women of childbearing age.
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