CMPX · Compass Therapeutics, Inc.

Compass Therapeutics disclosed compelling results from the COMPANION-002 Phase 2/3 trial of tovecimig (DLL4 x VEGF-A bispecific antibody) plus paclitaxel versus paclitaxel alone in 168 patients with advanced BTC in the second-line setting. The trial met its primary endpoint of ORR with a statistically significant 17.1% versus 5.3% (p=0.031, BICR-assessed), including one complete response in the combination arm. The key secondary endpoint of PFS showed a highly significant improvement, with median PFS of 4.7 months versus 2.6 months (HR=0.44, p<0.0001), representing a 56% risk reduction. OS analyses were confounded by high crossover (54% of control arm, 31/57 patients), leading to 85% of all patients receiving tovecimig and a pooled median OS of 8.9 months; ITT OS was 8.9 vs 9.4 months (HR=1.05, p=0.78). Post-hoc analyses highlighted crossover patients' benefits, with median OS of 12.8 months versus 6.1 months for non-crossover (HR=0.54, p=0.04), despite faster initial progression on paclitaxel monotherapy (1.9 vs 3.6 months PFS). Pre-specified PFS2 in crossover patients also improved significantly (3.5 vs 1.9 months, HR=0.36, p=0.0016). Safety was consistent with prior studies, with no new signals; hypertension and fatigue were most common, and Grade 3+ events included hypertension (44%) and neutropenia (36%). These results position tovecimig as a potential new standard in second-line BTC without actionable mutations, where current chemotherapy benchmarks show ~5% ORR and ~6 months OS. The company intends to engage FDA soon for BLA discussions, with full data including DoR to be presented at a medical conference later in 2026. This advances Compass's oncology pipeline focused on angiogenesis and immune modulation.