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:

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