New data show that addition of Zometa (zoledronic acid) to first-line chemotherapy significantly improved overall survival for newly diagnosed multiple myeloma patients by 16 per cent (P=0.0118) and progression-free survival by 12 per cent (P=0.0179) compared with oral clodronate plus first-line chemotherapy. The 5.5 month survival improvement demonstrated by Zometa in this study of nearly 2000 patients was independent of the drug's effect on bone complications (also known as skeletal-related events or SREs). Zometa was significantly superior to clodronate in the prevention of SREs associated with multiple myeloma, reducing the relative risk of SREs 24 per cent more than clodronate (P=0.0004).
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 tumours) 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 3.5 million patients worldwide.
"This is the first time we have seen in a large, phase-III independent trial that the addition of zoledronic acid to chemotherapy significantly improves survival in patients with multiple myeloma," said Dr Evangelos Terpos, Department of Clinical Therapeutics/Oncology Division, University of Athens School of Medicine, Alexandra General Hospital, Athens, Greece. "These data suggest that zoledronic acid has the potential to help multiple myeloma patients live longer."
Other Zometa data presented at ASCO include a five-year follow-up analysis from the phase-III Austrian Breast & Colorectal Cancer Study Group-12 (ABCSG-12) trial which showed that the addition of Zometa to hormonal therapy following surgery improved disease-free survival by 32 per cent (HR=0.68 [95%CI 0.51,0.91], P=0.009) in premenopausal women with hormone receptor-positive (HR+) early breast cancer. These data confirm earlier results from ABCSG-12 presented at ASCO 2008. Data from the ABCSG-12 study are the basis of the Company's US and European Union regulatory filings for Zometa in the treatment of adjuvant breast cancer.
"These five-year data are exciting for oncologists and patients alike because they confirm that adding zoledronic acid to a post-surgical hormonal treatment regimen can reduce the risk of cancer returning," said Michael Gnant, lead investigator and Professor of surgery at the Medical University of Vienna. "If approved for this indication, zoledronic acid may offer early breast cancer patients the opportunity to further reduce the risk of breast cancer returning, when added to post-surgery hormone therapy."
Zometa is indicated for the prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcemia) in patients with advanced malignancies involving bone.