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Published on 6 December 2010

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Zometa improves survival of multiple myeloma

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A newly published study in the Lancet suggested that a first-line treatment regimen including Zometa® (zoledronic acid) significantly improved overall survival (OS) and progression-free survival (PFS) in newly diagnosed multiple myeloma patients compared with a regimen that included oral clodronate.

The impact on survival was independent of the effect of Zometa on bone complications (also known as skeletal-related events or SREs).

The published results are from Medical Research Council (MRC) Myeloma IX, a large, randomized, Phase III clinical trial of nearly 2,000 patients with multiple myeloma.

These results were initially reported at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, in June 2010.

At a median follow-up of 3.7 years, Zometa significantly reduced the risk for death by 16% (hazard ratio [HR] 0.842; 95% confidence interval [CI] 0.74-0.96; P=0.0118) and the relative risk for PFS events by 12% (HR 0.88; 0.80-0.98; P=0.0179) compared with oral clodronate.

In addition to demonstrating superiority to clodronate on survival endpoints, Zometa was significantly superior to clodronate in the prevention of SREs associated with multiple myeloma, regardless of SRE history at baseline.

More than 750,000 cases of multiple myeloma are diagnosed each year worldwide, with a median overall survival of three to five years.

Nearly 95% of advanced stage multiple myeloma patients have bone disease and half of them will experience SREs (e.g., pathologic fractures, radiation or surgery to bone, spinal cord compression) if not treated.

“As a hematologist who treats patients with multiple myeloma, the survival benefit demonstrated by Zometa in this study is very encouraging,” said Professor Gareth Morgan, Head of Haemato-oncology at The Royal Marsden and The Institute of Cancer Research, UK and one of the study’s lead investigators.

“We have long known that Zometa is effective in the reduction of SREs, but these results suggest that there is a new role for Zometa in the treatment of multiple myeloma that may extend the life of patients battling this disease.”

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 (HCM).

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

“It is encouraging to see the improvement in both overall and progression-free survival in these patients with multiple myeloma,” said Hervé Hoppenot, President, Novartis Oncology.

“The findings of this large-scale trial add to the growing body of evidence that supports the potential anticancer effect of Zometa in multiple cancer types.”



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