Tovecimig (CTX-009) Meets Primary Endpoint in the Ongoing Randomized Phase 2/3 Study in Patients with Biliary Tract Cancer

Core Insights - Compass Therapeutics announced statistically significant top-line data from the COMPANION-002 trial, indicating the efficacy of tovecimig in combination with paclitaxel for patients with advanced biliary tract cancer (BTC) [1][2][6] Company Overview - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology [12] - The company aims to address critical biological pathways involved in tumor growth and angiogenesis [12] Clinical Trial Details - The COMPANION-002 trial is a Phase 2/3 randomized study involving 168 adult patients with unresectable advanced BTC, comparing tovecimig plus paclitaxel to paclitaxel alone [4][6] - Patients in the trial were randomized in a 2:1 ratio, with 111 receiving the combination therapy and 57 receiving paclitaxel alone [4] Efficacy Results - The primary endpoint of the trial, overall response rate (ORR), was 17.1% for the combination therapy compared to 5.3% for paclitaxel alone, demonstrating a statistically significant difference (p=0.031) [5][6][7] - The combination therapy also showed a lower progressive disease (PD) rate of 16.2% compared to 42.1% for paclitaxel alone [6][8] Patient Population and Need - Biliary tract cancer affects approximately 23,000 patients annually in the U.S., with 85% of patients lacking FDA-approved second-line treatment options [3] - Current second-line therapies have an ORR of ~5% or less, with a median overall survival of about six months [3] Future Expectations - The company plans to report additional data, including key secondary endpoints, in Q4 2025 [5][13] - Safety data will also be reported alongside the secondary endpoint analyses, with an independent Data Monitoring Committee recommending the continuation of the study without modifications [13]