FDA Tells Compass Therapeutics to Run Another Tovecimig Trial in Biliary Tract Cancer Before BLA Filing
核心洞察
The FDA has recommended an additional trial showing tovecimig improves overall survival in previously treated advanced biliary tract cancer (搜索) before Compass Therapeutics files its BLA.
The Phase 2/3 COMPANION-002 study met response and progression-free survival endpoints but did not show a statistically significant overall survival benefit.
Compass disagrees that a second trial is needed and will continue discussions with the FDA while preparing its Biologics License Application.
The U.S. Food and Drug Administration (搜索) has recommended that Compass Therapeutics conduct an additional trial demonstrating that tovecimig improves overall survival in patients with previously treated, advanced biliary tract cancer (搜索) (BTC), a step that could delay the company's path to commercialization of its lead oncology candidate.
The recommendation follows the Phase 2/3 COMPANION-002 study, which evaluated tovecimig in combination with paclitaxel against paclitaxel alone in this patient population. The trial produced positive results on two measures. Objective response rate, the proportion of patients with meaningful tumor shrinkage, was 18% with tovecimig versus 5.3% in the control group. Median progression-free survival was 4.7 months versus 2.6 months. The study did not demonstrate a statistically significant improvement in overall survival.
Company Disputes Need for Second Trial
Compass said it disagrees that another trial is necessary and plans further discussions with the agency while continuing to prepare its Biologics License Application (BLA). The company attributed the difficulty in interpreting the survival results to the fact that many patients in the control group later began receiving tovecimig, which it said made it harder to show a clear survival benefit between the two groups.
"While this is not the response we expected, we respect the FDA's feedback," CEO Thomas Schuetz said, adding that Compass remains confident in the study's results.
An additional trial would increase the company's costs. Compass ended June with about $180 million in cash and marketable securities, which it expects will fund operations into 2028.
Tovecimig Mechanism and Designations
Tovecimig is an investigational DLL4 (搜索) x VEGF-A (搜索) bispecific antibody designed to block two angiogenic pathways simultaneously, which Compass describes as a first-in-class approach to disrupting tumor angiogenesis. The candidate has received Fast Track and Orphan Drug Designation from the FDA.
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company that develops antibody-based therapeutics. The company was founded in 2014 and is headquartered in Boston, Massachusetts. Its pipeline targets the intersection of angiogenesis, immune activation, and tumor-driven immunosuppression.