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Denosumab superior in preventing skeletal-related events after prostate cancer bone metastases

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ASCO 2010 Annual Meeting

CHICAGO — Denosumab, a fully human antibody against the RANK ligand, delayed skeletal-related adverse events by as long as 3.6 months compared with zoledronic acid in men with bone metastases from castration-resistant prostate cancer.

“As far as I know, this was one of the largest phase 3 trials ever reported in patients with bone metastases for castration-resistant prostate cancer,” Karim Fizazi, MD, PhD, of the Institute Gustave Roussy Villejuif, France, said during his presentation. “Denosumab was superior to zoledronic acid in preventing or delaying first on-study skeletal-related events and also multiple skeletal-related events.”

The phase 3, randomized, double blind, active-controlled trial, led by Fizazi, compared the efficacy and safety of denosumab 120 mg plus IV placebo (n=950) vs. placebo plus IV zoledronic acid 4 mg (n=951) in 1,901 patients with metastatic castration-resistant prostate cancer.

All patients were assigned supplemental calcium and vitamin D. The primary endpoint was time to first skeletal-related event, such as a pathologic fracture, radiation or surgery to bone, or spinal cord compression.

Denosumab significantly delayed the time to first skeletal-related event when compared with zoledronic acid (HR=0.82; 95% CI, 0.71-0.95). Median time to first serious adverse event was 20.7 months for denosumab vs. 17.1 months for zoledronic acid.

Denosumab also significantly delayed the time to first and subsequent skeletal-related events (HR=0.82; 95% CI, 0.71-0.94).

Further, increased suppression of the bone turnover markers uNTx and BSAP occurred in denosumab patients (P<.0001 for both). Adverse events of hypocalcaemia were reported in 13% of those assigned denosumab and 6% of those assigned zoledronic acid. Osteonecrosis of the jaw occurred in 2.3% of those assigned denosumab vs. 1.3% of those assigned zoledronic acid (P=.09). – by Jennifer Southall

For more information:

• Fizazi K. #LBA4507. Presented at: the 2010 ASCO Annual Meeting; June 4-8; Chicago.

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