CMPX Tovecimig Study: PFS Improved 4.7 vs 2.6 Months in BTC
Compass Therapeutics announced positive results from its COMPANION-002 study for tovecimig (a DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel for biliary tract cancer. The study met its key secondary endpoint, demonstrating a statistically significant improvement in median progression-free survival (PFS) of 4.7 months versus 2.6 months for paclitaxel alone, representing a 56% reduction in progression risk. The previously announced primary endpoint of overall response rate (ORR) was also met, with 17.1% for the combination versus 5.3% for paclitaxel alone. While overall survival (OS) did not meet statistical significance due to high patient crossover (54%) to the tovecimig arm, a subset analysis showed crossover patients had a median OS of 12.8 months versus 6.1 months for non-crossover patients. The company plans to meet with the FDA for a Biologics License Application (BLA) submission.
Key Highlights
- Tovecimig + paclitaxel achieved median PFS of 4.7 months vs. 2.6 months for paclitaxel alone (p<0.0001).
- This represents a 56% reduction in progression risk for tovecimig combination.
- Primary endpoint ORR was 17.1% for combination vs. 5.3% for paclitaxel alone (p=0.031).
- OS secondary endpoint not met due to 54% patient crossover to tovecimig arm.
- Crossover patients showed median OS of 12.8 months vs. 6.1 months for non-crossover patients (p=0.04).
- Company plans to meet with FDA for a Biologics License Application (BLA) submission.
- Tovecimig was well tolerated; common Grade 3+ AEs: hypertension (44%), neutropenia (36%).
Price Impact
More from CMPX