Tovecimig Plus Paclitaxel Improves Response and PFS in Advanced Biliary Tract Cancer

In the randomized COMPANION-002 phase 2/3 trial, 168 patients with previously treated advanced biliary tract cancer received paclitaxel with or without tovecimig. The combination improved objective response and progression-free survival, but overall survival did not differ and grade 3 or higher adverse events were more frequent.

Objective response rate was 18.0% versus 5.3%.
Median PFS was 4.7 versus 2.6 months.
No overall-survival difference was observed.
Grade 3 or higher adverse events were more frequent with combination therapy.

COMPANION-002 was a randomized phase 2/3 trial of second-line treatment in 168 patients with advanced biliary tract cancer after one prior systemic therapy. Patients received paclitaxel with tovecimig, a bispecific antibody targeting delta-like ligand-4 and VEGF-A (n=111), or paclitaxel alone (n=57). The primary endpoint was objective response rate assessed by blinded independent central review; progression-free survival (PFS) and overall survival (OS) were secondary endpoints. Crossover to the combination after confirmed progression was allowed.

The combination improved objective response rate compared with paclitaxel alone (18.0% vs 5.3%; P=.0228) and median PFS (4.7 vs 2.6 months; hazard ratio, 0.44; P<.0001). No OS difference was observed (hazard ratio, 1.05; P=.779); 85% of participants received tovecimig, including 31 patients who crossed over. The most common treatment-emergent adverse events with the combination were hypertension (69.4%) and fatigue (66.7%). Grade 3 or higher events occurred in 93.5% with the combination and 64.2% with paclitaxel alone.

These results suggest improved response and disease control, but the absence of an OS difference and the higher rate of severe adverse events are important limitations. The supplied abstract does not provide further detail on follow-up or the full safety profile.

In practice

For patients with advanced biliary tract cancer previously treated with one systemic regimen, this randomized phase 2/3 trial found higher response and longer PFS with tovecimig plus paclitaxel than with paclitaxel alone. The findings do not establish an overall-survival benefit: OS did not differ, and crossover was common. Severe treatment-emergent adverse events were more frequent with the combination. These results are promising but, on the information provided, do not establish a basis for changing treatment practice.

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Source

Journal of Clinical Oncology: COMPANION-002: A Randomized Phase 2/3 Trial of Tovecimig Plus Paclitaxel versus Paclitaxel Alone as a Second-line Therapy in Patients with Advanced Biliary Tract Cancer ↗

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