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Published on 10 December 2010

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Novartis re-evaluates Zometa plans

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Results from the second interim analysis of the Phase III AZURE (Adjuvant Zoledronic acid to redUce REcurrence) trial show that Zometa® (zoledronic acid) did not demonstrate a disease-free survival (DFS) advantage when added to standard adjuvant (post-surgery) chemotherapy and/or hormonal therapy in pre- and postmenopausal women with early breast cancer.

In a preplanned 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.

The AZURE trial was conducted to determine if Zometa as adjuvant therapy had a benefit in preventing recurrences in premenopausal and postmenopausal women with early breast cancer.

The results were presented today at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium in San Antonio, Texas, US.

Zometa is currently approved for the reduction or delay of bone complications (skeletal-related events, or SREs) across a broad range of metastatic cancers (breast, prostate, lung and other solid tumors) involving bone and multiple myeloma, as well as for the treatment of hypercalcemia of malignancy (HCM) and is the most widely used bisphosphonate in the oncology setting.

“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.

“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.”

The potential anticancer benefit of Zometa was previously observed in a large, randomized, Phase III study from the Austrian Breast & Colorectal Cancer Study Group (ABCSG-12 study), which included more than 1,800 premenopausal women with hormone receptor-positive (HR+) early-stage breast cancer who, following curative surgery and hormone therapy, including goserelin treatment to suppress ovarian function and induce menopause, were treated with or without Zometa for three years.

The trial showed that the addition of three years of Zometa therapy to hormonal therapy following surgery improved disease-free survival by 32% (hazard ratio=0.68 [95% confidence interval 0.51-0.91], P=0.009).

Last year, Novartis filed supplemental marketing authorization applications for the adjuvant treatment of premenopausal women with HR+ early breast cancer in conjunction with hormonal therapy in the US and European Union (EU) based on the results of ABSCG-12.

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.

Zometa 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 tumors) involving bone, as well as for the treatment of hypercalcemia of malignancy.

It is the most widely used bisphosphonate in the oncology setting and has been used to treat more than 3.9m patients worldwide.



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