FDA tells Compass Therapeutics to run survival trial before BLA for tovecimig

Compass Therapeutics said on September 22, 2026 that the FDA recommended it conduct a trial demonstrating a survival benefit before proceeding with a Biologics License Application submission for tovecimig in patients with previously treated, advanced biliary tract cancer.¹

The company pushed back on that recommendation. Compass said it does not believe a new trial is warranted ahead of a BLA submission, pointing to the data from the Phase 2/3 COMPANION-002 study and what it called the urgent unmet medical need for BTC patients.¹ Compass said it plans to keep engaging with the FDA while continuing to prepare its BLA submission.¹

On the trial data, tovecimig plus paclitaxel showed a statistically significant improvement in the primary endpoint of objective response rate, 18.0% versus 5.3% for paclitaxel alone (p=0.0228), along with a highly significant progression-free survival improvement in previously treated BTC patients.¹ Median PFS was 4.7 months versus 2.6 months, with a hazard ratio of 0.44 (p<0.0001).¹ Overall survival results were confounded by high crossover and by notably prolonged survival among control-arm patients who crossed over to tovecimig, so OS did not reach statistical significance.¹ Compass said the safety profile was generally consistent with earlier tovecimig studies.¹

Tovecimig is described as an investigational DLL4 x VEGF-A bispecific antibody built to block two angiogenic pathways at once¹, and it has received Fast Track and Orphan Drug designations from the FDA.¹ The 8-K also noted Compass's intention to present the complete COMPANION-002 dataset at a medical conference during 2026, as stated in the filing's forward-looking statements regarding the expectation to present the complete dataset at a medical conference this year.¹