Aclasta: Additional Phase III data

Additional data from the open-label, international Phase III AZURE trial in 3,360 pre- and post-menopausal women showed that adjuvant treatment with Zometa plus standard chemotherapy and/or hormonal therapy led to a DFS rate, the primary endpoint, of 76.9% vs. 77.1% for standard therapy alone after a median follow-up of 59 months (p=0.79). Additionally, Zometa plus standard therapy led to an OS rate, a secondary endpoint, of 85.4% compared to 83.1% for standard therapy alone (p=0.07). There were 17 confirmed and 9 suspected cases of osteonecrosis of the jaw for Zometa plus standard therapy vs. 0 cases for standard therapy alone (p<0.001). Data were published in the New England Journal of Medicine. ...