Compass Therapeutics, Inc. (Nasdaq: CMPX) announced on September 22, 2026, that the U.S. Food and Drug Administration (FDA) has recommended that the company conduct a trial demonstrating a survival benefit before submitting a Biologics License Application (BLA) for tovecimig. The recommendation specifically applies to patients with previously treated, advanced biliary tract cancer (BTC).
The FDA’s feedback follows the completion of the Phase 2/3 COMPANION-002 study. In this trial, tovecimig was evaluated in combination with paclitaxel. The data showed a statistically significant improvement in the primary endpoint of objective response rate (ORR), which was 18.0% for the combination versus 5.3% for paclitaxel alone (p=0.0228). The study also demonstrated a highly significant improvement in progression-free survival (PFS), with a median PFS of 4.7 months compared to 2.6 months for paclitaxel alone (hazard ratio of 0.44; p<0.0001).
Compass Therapeutics stated that it does not believe a new trial is warranted prior to a BLA submission based on the data from COMPANION-002 and the urgent unmet medical need for patients with BTC. The company noted that overall survival (OS) analyses were confounded by high crossover rates and notably prolonged survival in crossover patients randomized to the control arm who subsequently received tovecimig, which prevented the data from meeting statistical significance.
Compass intends to further engage with the FDA as it continues to prepare for a BLA submission. The company remains confident in the potential of tovecimig, which has received Fast Track and Orphan Drug Designation from the FDA. Tovecimig is an investigational bispecific antibody designed to block two angiogenic pathways simultaneously.
