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Trial for colorectal cancer drug reaches primary endpoint

Aug. 17, 2022, 4:31 PM


by Tom Wilemon

A new therapy for metastatic colorectal cancer that has been granted fast track designation by the U.S. Food and Drug Administration has met its primary endpoint of overall survival in a phase 3 clinical trial, the FRESCO 2 study.

Cathy Eng, MD, David H. Johnson Professor of Surgical and Medical Oncology and co-leader of the Gastrointestinal Cancer Research Program at Vanderbilt-Ingram Cancer Center, is the U.S. senior national principal investigator and co-principal investigator for the FRESCO 2 study, an international clinical trial for patients with advanced, refractory metastatic colorectal cancer.

“Completion of the international FRESCO-2 phase 3 trial in a timely fashion during the era of COVID-19 isolation demonstrates the unmet need for new therapeutic agents in metastatic colorectal cancer,” Eng said. “By meeting the primary endpoint of overall survival with a secondary endpoint of progression-free survival, fruquintinib provides a significant potential new option for our refractory colorectal cancer patients. As an oral agent, fruquintinib also provides added convenience for our patients. Based on fruquintinib’s profile, we will likely see further exploration in future clinical trials in different settings. This is extremely encouraging, and I look forward to seeing the final results.”

The FRESCO-2 study, which was conducted in the U.S., Europe, Japan and Australia, investigated fruquintinib plus best supportive care versus placebo plus best supportive care in patients with metastatic CRC who had progressed on standard chemotherapy and relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib.

In addition to overall survival, a statistically significant improvement in progression-free survival, a key secondary endpoint, was observed. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported studies. Full results will be submitted for presentation at an upcoming medical meeting.

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