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Phase III Trial For New Bisphosphonate Type Drug, Denosumab

Home/Phase III Trial For New Bisphosphonate Type Drug, Denosumab

Phase III Trial For New Bisphosphonate Type Drug, Denosumab

The Myeloma Beacon ran this article a month or two ago about denosumab, a new drug thought to be easier and safer to use than Zometa:

Amgen recently released results from its Phase 3 clinical trial that compared denosumab with Zometa (zoledronic acid) in advanced cancer patients whose tumors have spread to the bone. The results indicated that denosumab delayed skeletal related events in this group of cancer patients.

Tumors that migrate to bone tissue, called bone metastases, are a major concern for patients with advanced multiple myeloma. Bone metastases often weaken and destroy the bone surrounding the tumor, resulting in serious complications that include bone fractures, spinal cord compression, the need for radiation, and the need for bone surgery. These complications are collectively named “skeletal related events,” or SREs for short. Nearly 100 percent of myeloma patients experience SREs due to bone metastases.

Denosumab specifically targets RANK Ligand, which regulates the cells that break down bone. The Phase 3 trial evaluated the efficacy of denosumab in the treatment of bone metastases by comparing it to Zometa, a current standard treatment for bone metastases. Zometa is a bisphosphonate that is used to prevent skeletal fractures in myeloma patients and to treat pain related to bone metastases.

The trial enrolled 1,776 advanced cancer patients in a randomized, double-blind study. Patients were randomly selected, in a one-to-one ratio, to receive either 120 mg of denosumab subcutaneously every four weeks or Zometa administered intravenously at a dose of 4 mg delivered as a single, 15-minute infusion every four weeks.

Patients receiving denosumab had a median time of 20.6 months until the occurrence of their first SRE, whereas patients receiving Zometa had a median time of 16.3 months. Despite being numerically greater, the average time until the first SRE was not statistically greater for denosumab compared to Zometa. The rate of adverse events (96 percent denosumab, 96 percent Zometa) and rate of serious adverse events
(63 percent denosumab, 66 percent Zometa) were similar for the two treatment groups, which is consistent with previous reports for these two drugs.

“The positive results of this study, combined with the convenience of a monthly subcutaneous injection and without the flu-like symptoms associated with Zometa administration, make this an exciting potential treatment option for advanced cancer patients,” said Dr. David Henry of Pennsylvania Hospital in Philadelphia.

All four myeloma experts at last months IMF conference raved about denosumab. Let’s hope it gains FDA approval soon.
Feel good and keep smiling! Pat