Compass Therapeutics says FDA urges survival-benefit trial before tovecimig BLA 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.

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