Bayer liver cancer drug trial shows positive outcome

Bayer Pharmaceuticals and Onyx Pharmaceuticals have announced that, following a safety and efficacy review of their phase III clinical trial of patients with advanced hepatocellular carcinoma (HCC) by an independent data-monitoring committee, the trial met its primary endpoint in patients receiving Nexavar (sorafenib).

Consequently, the committee recommended that the trial be stopped, with all patients previously enrolled being granted access to the compound. The companies have announced they will stop the trial and continue talks with regulatory bodies regarding the approval of the drug as a treatment for HCC.

Nexavar is an orally-administered multi-kinase inhibitor that targets tumour vasculature and tumour cells, with preclinical trials suggesting that blocking the Raf-1 kinase may offer benefits in the treatment of primary liver cancer.

Dr Jordi Bruix, co-principal investigator, said: “The observed superiority in overall survival for Nexavar-treated patients over patients receiving placebo demonstrates the efficacy of Nexavar in advanced primary liver cancer.”

Co-principal investigator Dr Josep M Llovet added that the results of this trial indicated the potential for novel options for the treatment of HCC.

In December 2006, the companies reported the results of a phase III clinical trial showing that the administration of Nexavar in combination with chemotherapeutic compounds carboplatin and placlitaxel did not meet its primary endpoint of enhancing progression-free survival.