Tovecimig (CTX-009 (DLL4 X VEGF-A bispecific)) - (COMPANION-002)

Sept. 22, 2026: Compass Therapeutics, Inc. (NASDAQ: CMPX) said the FDA recommended a trial showing an overall survival benefit before the company proceeds with a BLA submission for tovecimig in previously treated, advanced biliary tract cancer. Compass said it disagrees that a new trial is warranted before filing and plans further FDA engagement while continuing BLA preparations.

The update follows the Phase 2/3 COMPANION-002 study of tovecimig plus paclitaxel versus paclitaxel alone in previously treated BTC. The trial met its primary endpoint, with objective response rate of 18.0% vs. 5.3% (p=0.0228), and showed improved progression-free survival of 4.7 vs. 2.6 months (HR 0.44; p<0.0001). Overall survival was not statistically significant; the company said OS analyses were confounded by high crossover and prolonged survival in crossover patients. Safety was generally consistent with prior tovecimig studies.

Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody and has FDA Fast Track and Orphan Drug designation.