(ChemotherapyAdvisor) – A randomized phase 3 trial comparing first-line treatment with the investigational compound brivanib vs sorafenib in patients with advanced hepatocellular carcinoma did not meet its primary overall survival end point based on a noninferiority statistical design, Bristol-Myers Squibb Company reported.
The double-blind BRISK-FL study randomized patients in 179 centers worldwide to oral brivanib 800mg/day and oral placebo twice daily or oral sorafenib 800mg twice daily and oral placebo once daily. Estimated enrollment was 1,050 patients.
Brivanib is an investigational, oral, anti-tumorigenic that inhibits vascular endothelial growth factor receptor and fibroblast growth factor receptors.
Bristol-Myers Squibb noted it has shared BRISK-FL results with the clinical trial investigators and will work with them in the ongoing management of patients still receiving the study drug. Results of BRISK-FL will be reported at a future scientific meeting.