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Treatment with tovecimig, formerly known as CTX-009, elicited responses in patients with biliary tract cancer, according to COMPANION-002 study results.
Tovecimig elicited responses in biliary tract cancer in the COMPANION-002 study: © LIGHTFIELD STUDIOS - stock.adobe.com.
The bispecific antibody tovecimig (formerly CTX-009) elicited responses among patients with biliary tract cancer receiving treatment in the second-line setting, according to recently announced study findings.
The findings from the phase 2/3 COMPANION-002 study were announced in a news release from the clinical-stage, oncology-focused biopharmaceutical company Compass Therapeutics, Inc. Findings showed that treatment with tovecimig in combination with paclitaxel chemotherapy resulted in an overall response rate of 17.1%, including one complete response, versus 5.3% with paclitaxel alone.
Overall response rate: patients who had s partial or complete response to treatment.
Complete response: the disappearance of cancer.
Progression-free survival: the time a patient lives without their disease spreading or worsening.
Overall survival: the time a patient lives, regardless of disease status.
"We are thrilled to share these positive primary endpoint data from the COMPANION-002 study of tovecimig in patients with advanced biliary tract cancer," Dr. Thomas Schuetz, CEO of Compass and vice chairman of the Board of Directors, said in the news release. “We would like to thank all of the patients and their caregivers who have participated and continue to participate in this study. 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 these data with regulatory authorities."
The COMPANION-002 study enrolled 168 patients with unresectable advanced, metastatic or recurrent biliary tract cancers who had received a prior systemic chemotherapy regimen, with 111 receiving tovecimig plus paclitaxel and 57 receiving paclitaxel alone.
The study showed progressive disease rates of 16.2% for patients treated with tovecimig plus paclitaxel and 42.1% for those who received paclitaxel alone. According to the new release, the pre-specified number of events required for analysis of progression-free survival, overall survival and duration of response have not been reached yet, with the company expecting to report those results in the fourth quarter of 2025.
The study, being held at 34 sites across the United States, has an estimated primary completion date of July 2025, and an estimated study completion date of December 2025, according to the trial information listing on clinicaltrials.gov.
“As a treating clinician for over 20 years, I have seen firsthand how challenging a disease biliary tract cancer is. Patients currently have very limited treatment options, with the vast majority in the second-line setting having no approved therapeutic alternative whatsoever. “For every statistic, there is a person — a mother, father, relative, or friend — fighting for more time. Each investigative trial helps in this fight to advance new treatment options, and I look forward to following tovecimig’s continued progress,” said Dr. Juan Valle, Chief Medical Officer of the Cholangiocarcinoma Foundation, in the news release.
Tovecimig, as explained by the National Cancer Institute, is a bispecific antibody that may interfere with the ability of tumor cells to grow and spread, with bispecific antibodies being types of proteins that bind to targets in the body such as antigens, molecules that cause the body to make an immune response.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation to tovecimig in combination with paclitaxel in April 2024 for the treatment of patients with metastatic or locally advanced biliary tract cancers that have been previously treated.
Fast Tracking, according to the FDA’s website, is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Tovecimig, according to the National Cancer Institute, is also being studied in combination with gemcitabine, cisplatin and Imfinzi (durvalumab) as a first-line therapy among patients with unresectable or metastatic biliary tract cancers. That trial, being held at The University of Texas MD Anderson Cancer Center in Houston, is currently recruiting participants, according to its listing on clinicaltrials.gov.
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