Patients with metastatic colorectal cancer who had not responded to other treatments had “significant and clinically meaningful improvement” in overall survival when treated with the oral targeted therapy fruquintinib, according to findings from the phase 3 FRESCO-2 study presented in Paris during the European Society for Medical Oncology Congress.
The median overall survival was 7.4 months for patients treated with fruquintinib compared to 4.8 months for those who received placebo plus best supportive care. The patient population was allowed to have received all currently FDA-approved chemotherapy agents including TAS-102 or regorafenib or both. Currently, there are no approved effective treatments in the U.S. for metastatic colorectal patients who have progressed on standard treatments demonstrating the unmet need for new treatment options.
Cathy Eng, MD, the David H. Johnson Professor of Surgical and Medical Oncology, professor of Medicine and co-leader of the Gastrointestinal Cancer Research Program at Vanderbilt-Ingram Cancer Center, led the international trial as co-principal investigator.
“Our positive findings in this heavily pretreated patient population who had received a median of five prior lines of therapy noted an improvement of 2.6 months relative to the control for overall survival as well as a difference of 1.9 months progression-free survival,” said Eng.
The phase 3 clinical trial was conducted in the United States, Europe, Japan and Australia. Fruquintinib, which is a targeted therapy that inhibits the enzymes pivotal to a tumor’s ability to form blood vessels, was well-tolerated in addition to improving survival. Fruquintinib was tolerated well excluding hypertension in 13.6% of patients, fatigue in 7.7% and hand-foot syndrome in 6.4%.
The results from the FRESCO-2 trial support a new treatment option for refractory metastatic colorectal cancer. Fruquintinib was granted fast track designation in June 2020 by the U.S. Food and Drug Administration (FDA). The designation expedites the development and review of drugs that have the potential to fulfill unmet needs. China’s drug review agency approved fruquintinib in 2018 after a clinical trial there showed that the drug improved overall survival.
"I am delighted that Vanderbilt-Ingram Cancer Center co-led this global trial. Our findings clearly demonstrate the benefit of single agent oral fruquintinib for overall survival and progression-free survival in previously treated metastatic colorectal patients. FRESCO-2 demonstrates the importance of patient enrollment to clinical trials for drug discovery and new treatment options. We look forward to the submission to the FDA and the European Medicines Agency for a global indication as well as new upcoming trials in combination with fruquintinib," Eng said.