Clinical TrialJul 1, 2026, 05:06 PM
Compass Therapeutics Tovecimig Phase 2/3 Met Primary Endpoints
AI Summary
Compass Therapeutics, Inc. updated its corporate presentation, highlighting positive data from the COMPANION-002 clinical study for Tovecimig in second-line biliary tract cancer. The study met its primary endpoint of overall response rate (ORR) and significantly improved progression-free survival (PFS). Despite overall survival (OS) being confounded by patient crossover, a subset analysis showed improved OS in crossover patients. The company plans an FDA meeting in Q3 2026 and a Biologics License Application (BLA) submission in Q4 2026, targeting potential approval and launch in 2027. The update also provided timelines for other pipeline assets, CTX-8371 and CTX-10726.
Key Highlights
- Tovecimig COMPANION-002 study met primary ORR endpoint (18.0% vs 5.3%, p=0.0228).
- Tovecimig significantly improved PFS (4.7 vs 2.6 months, HR=0.44, p<0.0001).
- OS was confounded by crossover (8.9 vs 9.4 months, HR=1.05, p=0.78).
- Improved OS in crossover patients (12.8 vs 6.1 months, HR=0.54, p=0.04).
- Compass Therapeutics plans FDA meeting in Q3 2026 and BLA submission in Q4 2026.
- Potential Tovecimig approval and launch in 2027 for biliary tract cancer.
- CTX-8371 Phase 1 cohort expansion data expected H2 2026 for NSCLC, TNBC, HL.
- CTX-10726 Phase 1 data expected H2 2026 for post-PD-1 RCC, HCC, gastric, endometrial cancer.
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