According to the companies, in the international phase III trial, the survival of those patients receiving Nexavar was extended by 44%, or approximately three months, compared to those patients being treated with a placebo.
In addition, median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo, German company Bayer and it US partner Onyx said.
The primary objective of the study was to compare overall survival in patients administered with Nexavar versus those administered with a placebo. Bayer and Onyx halted the trial in February 2007, when an independent data monitoring committee determined in a pre-scheduled analysis that the overall survival endpoint had been met.
Based on the strength of the data, the companies are now in the process of preparing applications to the FDA and European health authorities for a supplemental indication for Nexavar in treatment of patients with liver cancer. The treatment is already approved for the treatment of kidney cancer.
Dr Jordi Bruix, co-principal investigator and director of the Barcelona Clinic Liver Cancer Group, said: “these results represent an unprecedented achievement and Nexavar could become the first widely-approved new therapy for this difficult to treat cancer.”
The results of the phase III trials of Nexavar, known generically as sorafenib, were presented at the forty-third annual meeting of the American Society of Clinical Oncology.