FDA grants Fast Track Designation for Compass's CTX-009 in biliary tract cancer

Compass Therapeutics, Inc.

FDA Fast Track Designation for CTX-009 (bispecific DLL4/VEGF-A antibody) + paclitaxel in previously treated metastatic/locally advanced biliary tract cancer.
Phase 2 data showed ORR 37.5% (9/24), median PFS 9.4 months, median OS 12.5 months.
Enrollment in Phase 2/3 COMPANION-002 study expected to complete mid-2024; top-line data by year-end 2024.
Co-founder Thomas Schuetz highlighted large unmet need with current single-digit response rates.

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