Amgen has posted more positive late-stage data on its eagerly-anticipated denosumab, which it plans to market as Prolia in osteoporosis and in bone loss associated with hormone therapy for breast cancer and prostate cancer, though the results were less impressive than those of another study published last month.
The company announced top-line results from a Phase III head-to-head trial evaluating denosumab administered subcutaneously versus Novartis’ intravenous infusion Zometa (zoledronic acid) in the treatment of bone metastases. The study involved 1,776 advanced cancer patients with solid tumours (not including breast and prostate cancer) or multiple myeloma.
The data showed that denosumab met its primary endpoint, ie patients treated with the drug experienced a similar time to first skeletal-related event (fracture, radiation to bone, surgery to bone, or spinal cord compression) compared with those receiving Zometa. However, Amgen noted that the delay in the time to first SRE associated with denosumab was not statistically superior compared to the Novartis drug.
The US biotechnology major also noted rates of osteonecrosis of the jaw “were balanced and infrequent in both treatment groups”, ten patients on denosumab compared with 11 patients receiving Zometa. This latest study comes a month after another Phase III trial involving 2,049 patients with advanced breast cancer demonstrated denosumab’s superior efficacy compared to Zometa.
Roger Perlmutter, head of R&D at Amgen, said the results of this latest study “continue to demonstrate that inhibiting RANK ligand with denosumab provides a clinically meaningful benefit for advanced cancer patients with solid tumours that have metastasised to the bone, and to patients with multiple myeloma, both groups who routinely suffer SREs”. He added that the firm is “very encouraged by the overall strength of the data” and is looking forward to reviewing the results of a final SRE study, in patients with advanced prostate cancer next year.
The latest data failed to thrill investors but analysts are still enthusiastic about the prospects for denosumab, with most predicting blockbuster status. Geoffrey Porges at Sanford Bernstein issued a note saying that the trial “still supports very strong positioning of denosumab in the market place, with a clearly positive study outcome and high likelihood of regulatory approval".
The US Food and Drug Administration’s Reproductive Health Drugs Advisory Committee is scheduled to meet next week (August 13) to review denosumab for osteoporosis in postmenopausal women, and bone loss in patients undergoing hormone ablation for prostate or breast cancer.
