fruquintinib therapy for metastatic colorectal cancer (CRC), granted fast-track designation by the FDA in June 2020, is being assessed in a phase 3 clinical trial at Vanderbilt-Ingram Cancer Center. Dr Cathy Eng, , David H Johnson Chair in Surgical and Medical Oncology at Vanderbilt University and co-leader of the Gastrointestinal Cancer Research Program at Vanderbilt-Ingram Cancer Center, is the US senior national principal investigator for the FRESCO 2 study, an international clinical trial for metastatic colorectal cancer for patients that have received (or are intolerant to) three prior lines of chemotherapy; patients must have been exposed to either regorafenib and/or lonsurf. Fruquintinib, which is designed to stop new blood vessels forming from pre-existing vessels that feed cancer tumours, is an oral small-molecule inhibitor of vascular endothelial growth factor.
In the randomised, double-blind trial, patients will be randomised in a 2:1 fashion to fruquintinib, plus supportive care. In the other arm (control arm), participants will receive placebo plus supportive care.
"This is the only phase 3 trial that I am aware of for metastatic colorectal cancer in the United States at this time," Eng said. There are no approved effective treatments in the US for metastatic colorectal patients who have progressed on standard treatments.
Fruquintinib was approved by the China Food and Drug Administration in 2018 for patients with metastatic colorectal cancer who had undergone at least two prior standard anticancer treatments. In a prior phase 3 clinical trial conducted in China involving 416 patients, overall survival was 9.3 months for patients who received fruquintinib versus 6.6 months for patients who received placebo.