Compass Therapeutics shared additional results from its Companion-002 Phase 2/3 program for the DLL4/VEGF-A bispecific tovecimig in second-line biliary tract cancer. The new data included mixed signals after the combo hit overall response rate earlier, with Wall Street focusing on that overall survival endpoint failing to be significant. The company said it plans to meet with the FDA to discuss a potential BLA. While OS was not significant in the intent-to-treat population and after adjusting for crossover, additional analyses reportedly showed improvements in progression-free survival and overall survival among crossover patients. The update highlights how trial design features such as crossover can complicate regulatory pathways even when key earlier endpoints are met.
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