Compass Therapeutics' Tovecimig Promising in Phase 2/3 Biliary Cancer Study

Compass Therapeutics has announced encouraging results from a phase 2/3 clinical trial of its experimental bispecific antibody, tovecimig, for treating biliary tract cancer (BTC). This study, known as the COMPANION-002 trial, is currently examining the efficacy of tovecimig, previously referred to as CTX-009, when used in combination with the chemotherapy drug paclitaxel. The trial participants consist of adults with inoperable advanced, metastatic, or recurrent BTC who have already undergone one systemic chemotherapy regimen.

The study's primary endpoint was achieved, as the combination of tovecimig and paclitaxel resulted in an overall response rate (ORR) of 17.1%, which included one complete response, in comparison to an ORR of 5.3% for patients treated with paclitaxel alone. Additionally, the rate of progressive disease was significantly lower in the combination treatment group, at 16.2%, compared to 42.1% for those receiving only paclitaxel. The safety profile of tovecimig was consistent with previous studies, indicating that the treatment is as safe as expected.

The analysis of secondary endpoints, such as progression-free survival, overall survival, and duration of response, is still pending due to the pre-specified number of events not yet being reached. Compass Therapeutics anticipates releasing data on these secondary measures by the fourth quarter of 2025.

Thomas Schuetz, CEO of Compass Therapeutics and Vice Chairman of the Board of Directors, expressed optimism about the findings, suggesting that tovecimig could become an essential treatment option for BTC patients who have exhausted first-line therapy options. Schuetz emphasized the company's eagerness to engage with regulatory authorities to discuss these promising results.

Biliary tract cancer is a rare and aggressive condition affecting the bile ducts, with approximately 23,000 new cases diagnosed annually in the United States. The majority of BTC patients experience disease progression after initial chemotherapy, highlighting the critical need for new, effective therapies. Tovecimig works by inhibiting both the Delta-like ligand 4 and vascular endothelial growth factor A signaling pathways, thereby delivering anti-tumor effects.

Juan Valle, the Chief Medical Officer of the Cholangiocarcinoma Foundation, highlighted the limited treatment options available for BTC patients, particularly in the second-line setting, where no approved therapeutic alternatives currently exist. Valle emphasized the importance of investigative trials like this one in advancing treatment possibilities for BTC and expressed his interest in the continued development and potential of tovecimig.

As Compass Therapeutics progresses with the tovecimig trial, the hope is to provide a new line of defense against biliary tract cancer, offering patients a much-needed alternative where few options currently exist. The findings from the COMPANION-002 trial represent a step forward in the quest to improve outcomes for those battling this challenging cancer.