US groups Bayer Pharmaceuticals Corp and Onyx Pharmaceuticals saw positive findings from an interim analysis of a late-stage clinical trial of Nexavar (sorafenib tosylate) presented at this week’s European Cancer Conference, which strongly indicated survival benefits in patients with kidney cancer.
Lead study investigator Dr Escudier reported data showing an estimated 39% improvement in survival for patients taking Nexavar compared to those receiving placebo. "These data build on the previously announced finding that disease progression was significantly delayed in advanced kidney cancer patients who received Nexavar. As a clinician who regularly sees individuals suffering from this disease, I am encouraged by this growing body of data and what they may mean for patients and their families," Dr Escudier stated.
This adds to positive results released earlier this year, which showed that Nexavar significantly prolonged progression-free survival. Based on the statistical and clinical significance of the progression-free data, the companies filed a New Drug Application with the US Food and Drug Administration, which granted a priority review for the treatment of advanced kidney cancer [[12/07/05c]]. A Marketing Authorization Application was subsequently submitted to the European Medicines Agency [[12/09/05d]].
Analysts predict great things for Nexavar after a dismal few years for Bayer, following the global withdrawal of its cholesterol-lowering drug Lipobay/Baycol (cerivastatin) [[08/08/0a]]. Sorafenib works as a Raf kinase inhibitor, blocking proliferation of a tumour and interfering with its blood supply and starving it of oxygen and nutrients, and many see it as one of the most important new compounds in Bayer's pipeline.