Amgen has announced positive results from a Phase III trial evaluating denosumab vs Zometa (zoledronic acid) for the treatment of bone metastases in 1,901 men with advanced prostate cancer.
During the trial, which met all endpoints, denosumab demonstrated superiority over Zometa for delaying the time to the first on-study skeletal related event (SRE), and reducing the rate of multiple SREs.
Overall rates of adverse events and serious adverse events, including infections, were generally similar between the two arms. As with previous studies in advanced cancer patients, hypocalcaemia was more frequent in the denosumab arm. Overall survival and the time to cancer progression were balanced between treatment arms.
Amgen Research and Development executive vice-president Roger Perlmutter said that the results demonstrate the ability of denosumab to delay bony complications in patients suffering from metastatic prostate cancer.
“Today’s results greatly enhance our understanding of the efficacy of denosumab in different tumour types,” Perlmutter said.
This study is the final of three pivotal trials in a total of over 5,700 advanced cancer patients investigated to determine the potential of denosumab to treat bone metastases.
These three studies will form the basis of the clinical evidence package for denosumab in advanced cancer, which will be submitted to regulatory authorities later this year.