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(denosumab, also known as AMC-162, trade name XGeva) is a bone resorption inhibitor with a unique mechanism of action. It specifically targets the receptor activator of NF-kB ligand (RANKL), inhibits osteoclast activation and development, reduces bone resorption, and increases bone density. Can be used for: prevention of bone-related events caused by bone metastasis from multiple myeloma and solid tumors. Treatment of giant cell tumor of bone in adults or skeletally mature adolescents where unresectable or surgical resection would result in serious complications.

Is denosumab effective in treating bone metastases?

Data on the safety and efficacy of denosumab for bone metastases from solid tumors come from three global randomized, double-blind controlled trials. In the three trials, patients were randomly assigned to denosumab (120 mg every four weeks) or zoledronate (4 mg every four weeks). Patients with creatinine clearance less than 30 mL/min were excluded. The primary endpoint of the trial was time to first bone-related events (SREs) that was non-inferior to zoledronic acid.

Study 20050136 (NCT00321464) included 2046 patients with advanced breast cancer with bone metastases. Forty percent of patients had experienced bone-related events, 40% had received chemotherapy within 6 weeks before randomization, 5% had received oral bisphosphonates, and 7% were from Japan. The median age of all patients was 57 years, 80% of patients were white, and 99% were female.

Study 20050244 (NCT00330759) enrolled 1,776 adults with bone metastases from solid tumors (excluding breast cancer, prostate cancer, multiple myeloma, etc.). At the time of randomization, 87% of patients were receiving systemic anticancer therapy, 52% had experienced a bone-related event, 64% were male, 87% were white, and the median age was 60 years. Among all patients, 40% had non-small cell lung cancer, 10% had multiple myeloma, 9% had renal cell carcinoma, and 6% had small cell lung cancer. Other types of tumors each account for no less than 5% of the enrolled population.

Study 20050103 (NCT00321620) included 1901 men with castration-resistant prostate cancer with bone metastases. 26% of patients had previous bone-related events, 15% had a PSA less than 10 ng/mL, and 14% had received chemotherapy within 6 weeks before randomization. The median age of all patients was 71 years, and 86% of patients were white.

The above three trial results show that compared with zoledronic acid, denosumab effectively delays the time to the first bone-related event.

Lung cancer and other solid tumors (including multiple myeloma): denosumab: 20.5 months vs. zoledronic acid: 16.3 months.

Lung cancer and other solid tumors (excluding multiple myeloma): denosumab: 21.4 months vs. zoledronic acid: 15.4 months.

Prostate cancer bone metastasis: denosumab: 20.7 months vs. zoledronic acid: 17.1 months.

Breast cancer bone metastasis: 60% of patients in the zoledronic acid group had no serious bone-related events within 27 months (end of trial) vs. more than 50% of patients in the zoledronic acid group had serious bone-related events before the end of the trial.