The COMPANION-002 trial press release from Compass Therapeutics reports that tovecimig, a DLL4 × VEGF-A bispecific antibody, combined with paclitaxel improved outcomes in patients with previously treated advanced biliary tract cancer. The study showed an objective response rate of 17.1% versus 5.3% with paclitaxel alone and significantly improved median progression-free survival to 4.7 months versus 2.6 months, reducing the risk of progression by 56%.
“In this study, tovecimig showed an impressive overall response rate which translated into a clinically meaningful and highly statistically significant improvement in PFS for patients with previously treated BTC. The remarkable 56% reduction in the risk of disease progression is unprecedented in this patient population without an actionable mutation in their tumor. It is also notable that the 31 crossover patients survived a median of 12.8 months, similar to the median OS seen in front-line studies in this setting. Including crossover, 85% of patients in the study received tovecimig in combination with paclitaxel and the pooled median OS for all patients in the study was 8.9 months, which is also substantially longer than chemotherapy benchmarks of approximately 6 months.”
said Thomas Schuetz, MD, PhD, Chief Executive Officer of Compass.
Patients with advanced biliary tract cancer have an urgent need for better treatment options. These results are a significant step forward and I anticipate that, if approved, it will meaningfully change the way physicians care for these patients. I also applaud Compass for putting patients first in the design of this study by allowing patients to crossover to receive treatment with tovecimig. These patients clearly benefited from this innovative therapy. I look forward to supporting Compass as they work to bring tovecimig to patients with cholangiocarcinoma.”
said Juan Valle, MD, Chief Medical Officer of the Cholangiocarcinoma Foundation.
About The COMPANION-002 Trial
COMPANION-002 is a Phase 2/3 randomized, controlled study evaluating tovecimig plus paclitaxel in adults with unresectable advanced, metastatic, or recurrent biliary tract cancer who had received one prior systemic chemotherapy regimen. The trial enrolled 168 patients, randomized 2:1 to receive tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57), with objective response rate as the primary endpoint and progression-free survival, overall survival, and duration of response as key secondary endpoints.
Results
The COMPANION-002 study demonstrated that tovecimig in combination with paclitaxel improved clinical outcomes compared with paclitaxel alone in patients with previously treated biliary tract cancer. The trial met its primary endpoint, with a significantly higher objective response rate of 17.1% versus 5.3%, including one complete response. This benefit was supported by a statistically significant improvement in progression-free survival, with a median of 4.7 months compared to 2.6 months, corresponding to a 56% reduction in the risk of disease progression.
Although the overall survival endpoint was not met, interpretation was limited by substantial treatment crossover, with 54% of patients in the control arm receiving tovecimig after progression. As a result, 85% of all patients were ultimately exposed to tovecimig, and the pooled median overall survival across the study reached 8.9 months. Notably, patients who crossed over experienced a median overall survival of 12.8 months, compared with 6.1 months in those who remained on chemotherapy alone, suggesting a potential survival benefit associated with tovecimig exposure.
Additional analyses further supported clinical activity, showing improved progression-free survival after crossover (3.5 vs 1.9 months) despite these patients initially having more aggressive disease. Safety findings were consistent with prior experience, with no new signals identified. The most common adverse events included hypertension and fatigue, while the most frequent severe toxicities were hypertension and neutropenia.
Overall, these results highlight meaningful anti-tumor activity and a manageable safety profile for tovecimig in a setting where treatment options remain limited and outcomes are typically poor.
About Tovecimig
Tovecimig is an investigational bispecific antibody engineered to simultaneously inhibit Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A), two key pathways involved in tumor angiogenesis and vascular development. Both preclinical and clinical evidence suggest that dual targeting of these pathways may enhance anti-tumor activity across a range of solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancers.
Conclusion
The COMPANION-002 results suggest that tovecimig plus paclitaxel may offer a meaningful treatment advance for patients with previously treated advanced biliary tract cancer. The combination improved objective response rate and significantly prolonged progression-free survival compared with paclitaxel alone, while maintaining a manageable safety profile. Although overall survival was difficult to interpret because of high crossover from the control arm, the additional analyses support further evaluation of tovecimig as a potential second-line option in this difficult-to-treat disease setting.