Compass Therapeutics has shared promising results from a phase 2/3 study of its investigational bispecific antibody in biliary tract cancer (BTC).
The ongoing COMPANION-002 trial has been evaluating the candidate, tovecimig (formerly CTX-009), alongside paclitaxel in adults with unresectable advanced, metastatic or recurrent BTC who have received one prior systemic chemotherapy regimen.
The study met its primary endpoint, with tovecimig plus paclitaxel achieving a 17.1% overall response rate (ORR), including one complete response, compared to an ORR of 5.3% for paclitaxel alone.
The tovecimig combination was also associated with progressive disease rates of 16.2% compared to 42.1% in patients on paclitaxel alone, and the safety profile of Compass’ drug was found to be consistent with prior studies.
The pre-specified number of events required to inform the analyses of the study’s secondary endpoints, including progression free survival, overall survival and duration of response, have not yet been met and the company said it is expecting to report results for these endpoints in the fourth quarter of 2025.
Thomas Schuetz, chief executive officer of Compass and vice chairman of the board of directors, said: “We believe these findings highlight the potential of tovecimig to provide a much-needed treatment option for the majority of patients with BTC who have limited alternatives after first-line therapy. We look forward to discussing this data with regulatory authorities.”
Around 23,000 cases of BTC, a rare and aggressive cancer of the bile ducts, are diagnosed in the US every year. Nearly all patients develop progressive disease following first-line treatment with chemotherapy, Compass outlined, underscoring the need for safe and effective therapies in patients with advanced BTC.
Tovecimig is designed to block both the Delta-like ligand 4 and vascular endothelial growth factor A signalling pathways, providing anti-tumour activity.
“Patients currently have very limited treatment options, with the vast majority in the second-line setting having no approved therapeutic alternative whatsoever,” said Juan Valle, chief medical officer of the Cholangiocarcinoma Foundation. “Each investigative trial helps in this fight to advance new treatment options, and I look forward to following tovecimig’s continued progress.”
