The COMPANION-002 trial tested Tovecimig (CTX-009) combined with paclitaxel in patients with advanced biliary tract cancer who had already received prior treatment. The combination worked better than paclitaxel alone, nearly doubling progression-free survival to 4.7 months compared with 2.6 months. Tumor response rates were also higher, with 17.1% of patients responding versus 5.3% in the chemotherapy-only group.
Overall survival did not improve in the main analysis, showing 8.9 months with the combination versus 9.4 months with paclitaxel alone. However, more than half of patients in the control group later switched to Tovecimig after their cancer progressed. Those who switched lived much longer (12.8 months) than those who did not (6.1 months), suggesting the drug may still provide a survival benefit.
Side effects were manageable and similar to previous studies, with high blood pressure and fatigue being the most common. Serious side effects included hypertension and low white blood cell counts. The study highlights a potentially important new option for biliary tract cancer.