Aclasta: Interim Phase III data

Novartis said it will withdraw regulatory applications in the U.S. and EU for Zometa for the adjuvant treatment of early breast cancer in premenopausal women after the IV bisphosphonate missed the primary endpoint in the open-label, international Phase III AZURE trial in 3,360 pre- and post-menopausal women. Adjuvant treatment with Zometa plus standard chemotherapy and/or hormonal therapy did not significantly improve disease-free survival vs. standard therapy alone after a median follow-up of 59 months (p=0.79). Zometa plus standard therapy also missed the secondary endpoint of significantly improving OS vs. standard therapy alone (p=0.0726). The pharma plans to discuss next steps with health authorities.

Additionally, a preplanned subgroup analysis of patients with well-established menopause showed that Zometa plus standard therapy significantly improved OS by 29% vs. standard therapy alone (p=0.017), but missed the endpoint in premenopausal women. Data were presented at the San Antonio Breast Cancer Symposium. Novartis previously reported data from a neoadjuvant subset of 205 patients enrolled in AZURE showing that Zometa plus standard therapy significantly reduced mean tumor size vs. standard therapy alone (see BioCentury, Dec. 22, 2008). ...