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Zometa trial fails to meet primary endpoint

Novartis has announced that a phase III trial investigating Zometa for use in early breast cancer did not meet primary endpoint

Novartis has announced that results from the second interim analysis of the phase III AZURE trial for the drug Zometa (zoledronic acid) for potential new use in early breast cancer did not meet primary endpoint in the overall study population. The results did not demonstrate a disease-free survival advantage when Zometa was added to standard adjuvant (post-surgery) chemotherapy and/or hormonal therapy in pre- and postmenopausal women with early breast cancer.

Current applications in the US and EU for adjuvant treatment in early breast cancer will be withdrawn and Novartis intend to evaluate future plans based on these new data.

The study results do not impact the current indications for Zometa in preventing skeletal-related events (SREs) in patients with advanced cancers involving bone and multiple myeloma and treating hypercalcaemia of malignancy (HCM).

The drug is approved in more than 100 countries for the reduction or delay of bone complications in multiple myeloma, and across a broad range of metastatic cancers (breast, prostate, lung and other solid tumours) involving bone, as well as for the treatment of hypercalcaemia of malignancy. It has been used to treat more than 3.9m patients worldwide.

"These trial results do not impact the current usage of Zometa, which continues to be a critical treatment for many patients with a broad range of metastatic cancers and multiple myeloma," said Hervé Hoppenot, president, Novartis Oncology.

Hoppenot added: "Although we did not see an overall disease free survival advantage for early breast cancer patients receiving Zometa in the adjuvant setting, we're encouraged that a subset of postmenopausal patients in the trial experienced an improvement."

Last year, Novartis filed supplemental marketing authorisation applications for the adjuvant treatment of premenopausal women with HR+ early breast cancer in conjunction with hormonal therapy in the US and EU based on the results of a phase III study from the Austrian Breast & Colorectal Cancer Study Group (ABSCG-12 study). Novartis is currently reviewing the data from the AZURE trial results, which were expected to be added to the submission. In the meantime, Novartis will withdraw the current marketing applications and discuss next steps with health authorities.

13th December 2010

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