Key insights
- The FDA has requested Compass Therapeutics Inc. conduct an additional survival trial for its drug tovecimig before accepting a Biologics License Application for biliary tract cancer. Compass believes the data is sufficient and intends to engage further with the FDA. While the drug showed improved objective response rate and progression-free survival in a Phase 2/3 study, overall survival did not meet statistical significance.
BOSTON - The U.S. Food and Drug Administration has recommended that Compass Therapeutics Inc. (NASDAQ:CMPX) conduct a trial demonstrating a survival benefit before submitting a Biologics License Application for tovecimig in patients with previously treated, advanced biliary tract cancer, according to a press release statement issued today.
Compass stated it does not believe a new trial is warranted prior to submitting a BLA based on data from the Phase 2/3 COMPANION-002 study. The company intends to further engage with the FDA as it continues to prepare a BLA submission.
In the COMPANION-002 study, tovecimig plus paclitaxel demonstrated a statistically significant improvement in the primary endpoint of objective response rate of 18.0% versus 5.3% with paclitaxel alone (p=0.0228). Median progression-free survival was 4.7 months versus 2.6 months with a hazard ratio of 0.44 (p<0.0001), representing a 56% reduction in the risk of disease progression.
Overall survival analyses did not meet statistical significance. The company attributed this to high crossover rates and prolonged survival in crossover patients randomized to the control arm who were then treated with tovecimig.
Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody designed to block two angiogenic pathways simultaneously. The drug has received Fast Track and Orphan Drug Designation from the FDA.
Biliary tract cancer is characterized by poor survival outcomes, with limited treatment options available for patients who have received prior treatment.
Thomas Schuetz, Chief Executive Officer of Compass, stated the company’s priority is to work with the FDA to determine the best path forward to support the planned BLA submission.
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