Compass Therapeutics Reports 56% PFS Risk Reduction, 17.1% ORR in Biliary Cancer Study
Compass Therapeutics’ bispecific antibody tovecimig plus paclitaxel improved median progression-free survival to 4.7 months versus 2.6 months, a 56% reduction in progression risk, and raised overall response rate to 17.1% from 5.3%. The company plans a Biologics License Application submission after an FDA meeting.
1. Study Efficacy Results
Tovecimig with paclitaxel achieved median PFS of 4.7 months versus 2.6 months for paclitaxel alone (HR=0.44, p<0.0001) and improved overall response rate to 17.1% compared with 5.3% in the control arm (p=0.031) in patients with unresectable biliary tract cancer.
2. Crossover Effects on Survival
High crossover—54% of control patients switched to tovecimig—confounded overall survival analysis, yielding a median OS of 8.9 months across all patients and 12.8 months in crossover patients versus 6.1 months in non-crossover control patients (HR=0.54, p=0.04).
3. Regulatory Outlook
Compass plans to meet with the FDA ahead of a Biologics License Application submission and will present complete data, including duration of response, at an upcoming medical conference, aiming to bring tovecimig to patients with limited second-line treatment options.