Amgen Reports Positive Results For Phase 3 Denosumab Study

Amgen has reported positive top-line results from a pivotal phase 3 head-to-head trial evaluating denosumab.

The study of denosumab, administered subcutaneously versus Zometa administered as an intravenous (IV) infusion, in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors or multiple myeloma.

For the primary endpoint, patients treated with denosumab experienced a similar time to first skeletal-related event (SRE) compared to those receiving Zometa, which is statistically significant for non-inferiority.

Although numerically greater, the delay in the time to first SRE associated with denosumab treatment was not statistically superior, as compared to Zometa (secondary endpoint).

Roger Perlmutter, executive vice president of Research and Development at Amgen, said: We are extremely pleased with these results, which continue to demonstrate that inhibiting RANK Ligand with denosumab provides a clinically meaningful benefit for advanced cancer patients with solid tumors that have metastasized to the bone, and to patients with multiple myeloma, both groups who routinely suffer SREs.

We are very encouraged by the overall strength of the data, which we will present in a scientific forum later this year. We are also looking forward to reviewing the results of a final SRE study, in patients with advanced prostate cancer, next year, he added.