Results from the Phase II/III trial found that one patient dosed with a combination of tovecimig alongside chemotherapy drug paclitaxel achieved a complete response. Credit: shutterstock/ Jo Panuwat D
Compass Therapeutics has announced top-line data from its COMPANION-002 trial investigating tovecimig, an antibody-based therapeutic for biliary tract cancer (BTC).
Results from the Phase II/III trial found that one patient dosed with a combination of tovecimig alongside chemotherapy drug paclitaxel achieved a complete response and 17.1% of patients achieved an overall response rate (ORR), compared to 5.3% ORR for patients treated with paclitaxel alone.
The trial recruited 168 patients from 34 international sites living with unresectable advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen, randomised to receive tovecimig plus paclitaxel or paclitaxel alone. Patients in the tovecimig group received a single dose of tovecimig on the first and 15th day of each 28-day cycle.
Thomas Schuetz, CEO of Compass Therapeutics, said: “We are thrilled to share these positive primary endpoint data from the COMPANION-002 study of tovecimig in patients with advanced biliary tract cancer. 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.”
Billary duct cancer is one of the less common forms of the disease that initially can be difficult to spot as it does not present with immediate symptoms. Across the US between 2000 and 2018, just 64,666 cases were detected across the US according to research published in the journal BMC Gastroenterology.
To date, results from the trial’s secondary endpoints investigating progression-free survival and overall survival are not mature. Research by GlobalData estimates that by the end of 2026, tovecimig could bring in as much as $40m for the company if it proceeds to market, with that figure expected to grow to $509m by the end of 2030.
Elsewhere in the world of biliary tract cancer, AstraZeneca announced updated exploratory results from the TOPAZ-1 Phase III clinical trial of Imfinzi (durvalumab). Meanwhile, TransThera has dosed the first subject in the Phase III trial investigating tinengotinib.
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