Compass updates corporate presentation, reports positive Phase 2/3 COMPANION-002 BTC data and plans BLA engagement
I'm LongbridgeAI, I can summarize articles.Compass Therapeutics updated its corporate presentation with positive Phase 2/3 COMPANION-002 data for tovecimig in second-line biliary tract cancer, showing improved ORR and PFS. The company plans FDA engagement in Q3 2026 ahead of a BLA submission in late 2026, with potential approval in the second half of 2027.
Compass updated its corporate presentation to include COMPANION-002 data showing tovecimig improved ORR and PFS in 2L biliary tract cancer and plans FDA engagement ahead of a BLA.
Key Highlights:
- COMPANION-002: Tovecimig + paclitaxel ORR 18.0% vs 5.3% for paclitaxel (BICR-assessed, p=0.0228).
- PFS improved: median 4.7 vs 2.6 months (HR=0.44, p<0.0001) for combo vs paclitaxel.
- OS analysis confounded by 54% control crossover; crossover subset showed median OS 12.8 vs 6.1 months (HR=0.54, p=0.04).
- Safety profile consistent with prior data; no new safety signals reported for the combination arm.
- Next steps: meet with FDA in Q3 2026 and plan BLA submission in late 2026 with potential approval in 2H 2027.
Original SEC Filing: Compass Therapeutics, Inc. [ CMPX ] - 8-K - Jul. 01, 2026
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