Clinical TrialApr 27, 2026, 07:32 AM
CMPX Tovecimig Phase 2/3 BTC Study: ORR 17.1%, PFS 4.7M
AI Summary
Compass Therapeutics announced detailed data from its COMPANION-002 Phase 2/3 study of tovecimig plus paclitaxel in biliary tract cancer (BTC). The study met its primary endpoint with an overall response rate (ORR) of 17.1% for the combination versus 5.3% for paclitaxel alone. Tovecimig also showed a statistically significant improvement in median Progression-Free Survival (PFS) of 4.7 months compared to 2.6 months. While the Overall Survival (OS) endpoint was not met in the ITT analysis due to high patient crossover, post-hoc analysis showed significant OS improvement in crossover patients. The company plans to meet with the FDA for a BLA submission.
Key Highlights
- Primary endpoint ORR: 17.1% for tovecimig combo vs. 5.3% for paclitaxel alone (p=0.031).
- Median Progression-Free Survival (PFS): 4.7 months for combo vs. 2.6 months for paclitaxel alone (p<0.0001).
- Overall Survival (OS) endpoint not met in ITT analysis (8.9 months vs. 9.4 months) due to 54% crossover.
- PFS in crossover patients (PFS2): 3.5 months with tovecimig vs. 1.9 months with paclitaxel (p=0.0016).
- OS in paclitaxel control arm: 12.8 months for crossover patients vs. 6.1 months for non-crossover (p=0.04).
- Safety profile: Generally well tolerated; common AEs hypertension (69%) and fatigue (67%).
- Company intends to meet with the US FDA for a planned Biologics License Application (BLA) submission.
Price Impact
More from CMPX