Novartis' bisphosphonate Zometa has impressed in a late-stage trial which suggests that the drug improves survival in multiple myeloma patients.
Data from a 1,960-patient Phase III study, which has been published in the Lancet, showed that Zometa (zoledronic acid) significantly improved both overall and progression-free survival in newly-diagnosed MM patients compared with a regimen that included another bisphosphonate, oral clodronate. At a median follow-up of 3.7 years, the Novartis drug significantly reduced the risk for death by 16% and the relative risk for PFS events by 12%.
In addition to demonstrating superiority to the latter on survival endpoints, the proportion of patients who experienced a skeletal related event (SRE ) was reduced by 24% in patients receiving Zometa versus clodronate. However, less positive was the incidence of confirmed osteonecrosis of the jaw in the Zometa and clodronate treatment arms - 4.0% and less than 1.0%, respectively.
Nevertheless, Gareth Morgan, head of haemato-oncology at The Royal Marsden and one of the study's lead investigators, was encouraged by the survival benefit demonstrated by the drug. He added that "we have long known that Zometa is effective in the reduction of SREs, but these results suggest that there is a new role...in the treatment of MM that may extend the life of patients battling this disease."
Herve Hoppenot, head of Novartis Oncology, said the findings "add to the growing body of evidence that supports the potential anticancer effect of Zometa in multiple cancer types". The drug is approved in more than 100 countries for the reduction or delay of bone complications in MM and across a broad range of metastatic cancers (breast, prostate, lung and other solid tumors) involving bone, as well as for the treatment of hypercalcaemia of malignancy.