Key insights
- Compass Therapeutics published positive Phase 2/3 trial results for tovecimig combined with paclitaxel in advanced biliary tract cancer. The combination met its primary endpoint of objective response rate (18.0% vs 5.3%) and key secondary endpoint of progression-free survival (4.7 vs 2.6 months). While overall survival did not show a statistically significant difference, a post hoc analysis adjusted for crossover suggested a potential benefit. Higher rates of grade 3+ adverse events were observed in the combination arm.
BOSTON - Compass Therapeutics, Inc. (NASDAQ:CMPX) announced the publication of results from its Phase 2/3 COMPANION-002 study evaluating tovecimig combined with paclitaxel in patients with previously treated advanced biliary tract cancer in the Journal of Clinical Oncology.
The randomized study enrolled 168 patients with advanced biliary tract cancer who had received one prior therapy, assigning them 2:1 to receive tovecimig plus paclitaxel or paclitaxel alone. The trial met its primary endpoint, showing an objective response rate of 18.0% versus 5.3% with paclitaxel alone, according to the press release statement.
The study also met its key secondary endpoint of progression-free survival, with a median of 4.7 months versus 2.6 months for paclitaxel alone, representing a 56% reduction in the risk of disease progression or death. The median duration of response was 4.9 months, and the disease control rate was 62.2% versus 36.8%.
In patients with intrahepatic cholangiocarcinoma, a prespecified subgroup comprising 92 of 168 patients, the objective response rate was 15.3% versus 0% and median progression-free survival was 5.1 versus 3.0 months.
The study allowed crossover from paclitaxel to tovecimig plus paclitaxel after disease progression. Thirty-one of 57 patients in the control arm crossed over, resulting in 85% of all study patients ultimately receiving tovecimig. The intent-to-treat overall survival analysis showed no statistically significant difference. A post hoc analysis using Two-Stage Estimation to adjust for crossover demonstrated an overall survival hazard ratio of 0.85.
Grade 3 or higher treatment-emergent adverse events occurred in 93.5% of patients in the combination arm and 64.2% receiving paclitaxel alone. Treatment-emergent adverse events leading to death occurred in 5.6% and 1.9% of patients, respectively.
Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody and has not been approved by the FDA.
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