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Compass Therapeutics Announces Publication of Phase 2/3 COMPANION-002 Results for Tovecimig in the Journal of Clinical Oncology and Oral Presentation at ESMO 2026

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  • Compass Therapeutics announced the publication of positive Phase 2/3 COMPANION-002 results for tovecimig plus paclitaxel in advanced biliary tract cancer (BTC) in the Journal of Clinical Oncology (JCO) & presentation at the 2026 ESMO Congress.
  • The study met its primary endpoint, showing a statistically significant improvement in Objective Response Rate (ORR) of 18.0% vs. 5.3% with paclitaxel alone (p=0.0228).
  • The key secondary endpoint of Progression-Free Survival (PFS) was met, with a median PFS of 4.7 vs. 2.6 months (HR=0.44, p<0.0001), representing a 56% reduction in the risk of disease progression or death.
  • Durability of response was observed with a median Duration of Response (DOR) of 4.9 months, & Disease Control Rate (DCR) significantly improved to 62.2% vs. 36.8% (p=0.0018).
  • In the prespecified intrahepatic cholangiocarcinoma subgroup (55% of patients), results showed an ORR of 15.3% vs. 0% (p=0.0258) & a median PFS of 5.1 vs. 3.0 months (HR=0.32).
  • Intent-to-treat Overall Survival (OS) analysis showed no statistically significant difference due to high crossover rates (54% of control patients switched to the combination), but a post hoc two-stage estimation adjusting for crossover yielded an OS hazard ratio of 0.85 (p=0.53).
  • Patients who crossed over from paclitaxel to the combination therapy demonstrated a median PFS of 3.5 months after switching, compared to 1.9 months on initial paclitaxel (HR=0.40, p=0.0035).
  • Safety profile remained consistent with prior tovecimig studies & the anti-VEGF class, with hypertension (69%) & fatigue (67%) being the most common treatment-emergent adverse events in the combination arm.
  • Grade 3 or higher adverse events occurred in 93.5% of patients in the combination arm vs. 64.2% in the paclitaxel alone arm, with treatment discontinuation rates of 27.8% vs. 11.3%, respectively.
  • Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody that has received Fast Track & Orphan Drug Designation from the FDA for the treatment of BTC.