FDA tells Compass to run survival trial before BLA for tovecimig; company disagrees

Compass Therapeutics, Inc.

FDA recommended a survival-benefit trial before BLA submission for tovecimig in biliary tract cancer (BTC).
Compass disagrees, citing COMPANION-002: ORR 18.0% vs 5.3% (p=0.0228); median PFS 4.7 vs 2.6 months, HR 0.44 (p<0.0001).
Overall survival missed statistical significance due to high crossover and prolonged survival in crossover patients.
Company plans further FDA engagement, intends to proceed with BLA; full data to be presented at a medical conference this year.
CEO Thomas Schuetz acknowledged the feedback and said priority is working with the FDA on the best path forward.

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