Novartis' Zometa fails to meet Ph III primary endpoint in early breast cancer, stalling this indication; but Afinitor looks good

Results from the second interim analysis of the Phase III AZURE (Adjuvant Zoledronic acid to redUce REcurrence) trial show that Swiss drug major Novartis; (NOVN: VX) Zometa (zoledronic acid) - which has been viewed as one of the most promising drugs in breast cancer and also is sold for the treatment of osteoporosis as Reclast - failed to demonstrate a disease-free survival (DFS) advantage when added to standard adjuvant (post-surgery) chemotherapy and/or hormonal therapy in pre- and post-menopausal women with early breast cancer.

However, in a pre-planned analysis based on menopausal status, a benefit in disease free survival and overall survival was seen in women with well-established menopause in the Zometa arm. Nevertheless, Herve Hoppenot, president of Novartis Oncology, said the company would withdraw applications in the USA, Europe and elsewhere to expand Zometa's use to pre-menopausal breast cancer patients like those in the earlier successful study, and will review the AZURE data with regulators.

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