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news.Merck & Co has reported positive results from a new Phase II study, which showed that oral odanacatib, the company's investigational selective cathepsin K inhibitor, reduced measures of bone turnover in women with breast cancer that has spread to the bones.
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This randomized, double-blind, multicenter study included 43 women with breast cancer and metastatic bone disease who received oral odanacatib 5mg daily or intravenous zoledronic acid 4mg on day one. The mean age of women was 60 years. The primary endpoints of the study were the marker of bone resorption urinary N-telopeptide of type I collagen corrected for creatinine and safety.
In this study, treatment with oral odanacatib 5mg once daily (n=29) reduced the level of urinary N-telopeptide (uNTx), a commonly used marker of bone resorption (breakdown), by 77% from baseline levels over four weeks. These results were seen as early as day seven, the first measurement point.
Treatment with intravenous zoledronic acid 4mg (n=14) reduced uNTx by 73%.
In addition, decreases in other markers of bone turnover, including the marker of bone resorption urinary deoxpyridinoline (uDPD) and the marker of bone formation serum bone-specific alkaline phosphatase (sBSAP) were observed with odanacatib; as was an increase in serum crosslinked C-terminal peptide (s1CTP), a marker of cathepsin K activity.
Antonio Lombardi, senior director at Merck Research Laboratories, said: “Based on these findings, larger Phase III studies using the 5mg daily dose of odanacatib are being planned for patients with breast and prostate cancer.”