THE "NEW" PROSTATE CANCER INFOLINK

Earlier today, Amgen announced that their investigational drug denusomab met the projected endpoints in a randomized, multicenter, Phase 3, placebo-controlled trial evaluating the drug in the management of bone loss in prostate cancer patients.

The study included more than 1,400 men with non-metastatic prostate cancer who were receiving androgen deprivation therapy (ADT). The basic results of the trial can be summarized as follows (based on Amgen’s media release):

• Denosumab therapy induced statistically significantly greater increases in bone mineral density (BMD) at the lumbar spine (primary endpoint) and non-vertebral sites compared with placebo at multiple time points.
• During the 36-month evaluation period, men receiving denosumab experienced less than half the incidence of new vertebral fractures (a secondary endpoint) compared with those receiving placebo.
• There were fewer non-vertebral fractures in the denosumab arm than in the placebo arm over the 36-month period.
• The incidence and types of adverse events observed in this study were generally similar between the denosumab and placebo groups.
• The most common adverse events across both treatment arms were arthralgia, back pain, constipation, and pain in extremity.
• Serious adverse infectious events occurred in approximately 5 percent of men receiving placebo treatment as compared with approximately 6 percent of those receiving denosumab.

Detailed results of this trial are not yet available, since prior announcement of the detailed results would prejudice publication of these data in the peer-reviewed scientific literature, which is presumably planned for some future data. We will have to wait to see these details.

According to Amgen, “Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK ligand, the essential regulator of osteoclasts (the cells that break down bone). … Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-induced bone disease. Over 11,000 patients are currently enrolled in denosumab oncology clinical trials testing the drug for bone loss associated with cancer treatment-induced bone loss in breast and prostate cancers, for the prevention of skeletal related events due to the spread of cancer to the bone in multiple myeloma and multiple solid tumors, and for its potential to delay bone metastases in prostate cancer. The denosumab oncology program has a specific commitment in prostate cancer, studying more than 4,300 patients to determine the treatment effect of denosumab to treat and prevent bone loss, treat and prevent SREs and delay bone metastases in men with prostate cancer.”

Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment |