Compass Therapeutics says FDA urges survival-benefit trial before tovecimig BLA in biliary tract cancer
CMPX•FDA feedback on tovecimig in biliary tract cancer
Compass Therapeutics disclosed FDA feedback urging a new study to show a survival benefit before a BLA for tovecimig in biliary tract cancer.
Results from the already reported COMPANION-002 trial showed improved tumor responses and delayed disease worsening versus chemotherapy alone.
Survival results did not reach statistical significance, with the analysis complicated by crossover from the control arm.
The company plans further FDA engagement while continuing preparations for a BLA submission without running an additional pre-filing trial.
