HUTCHMED (China) Limited recently announced that the global phase III FRESCO-2 trial evaluating the investigational use of the anti–vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor fruquintinib met its primary endpoint of overall survival in patients with advanced, refractory metastatic colorectal cancer.
The FRESCO-2 study is a multiregional clinical trial conducted in the United States, Europe, Japan, and Australia that investigated fruquintinib plus best supportive care vs placebo plus best supportive care in patients with metastatic colorectal cancer whose disease had progressed on standard chemotherapy and relevant biologic agents and who experienced disease progression on, or who were intolerant to, TAS-102 (trifluridine and tipracil) 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 the tyrosine kinase inhibitor in FRESCO-2 was consistent with previously reported studies. Full results will be submitted for presentation at an upcoming medical meeting.
HUTCHMED has been in communication with regulatory agencies globally regarding the FRESCO-2 trial design and conduct and will discuss these data with agencies in the United States, Europe, and Japan with the intent to submit marketing authorization applications. The U.S. Food and Drug Administration granted Fast Track designation in June 2020 for the development of fruquintinib in the treatment of patients with metastatic colorectal cancer.
Cathy Eng, MD, FACP, FASCO, the David H. Johnson Endowed Chair in Surgical and Medical Oncology and Co-Leader, Gastrointestinal Cancer Research Program, at the Vanderbilt-Ingram Cancer Center, who served as the FRESCO2 co-primary investigator and steering committee member commented: “Completion of the international FRESCO-2 phase III trial in a timely fashion during the era of COVID-19 isolation demonstrates the unmet need for new therapeutic agents in metastatic colorectal cancer. 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.”
Weiguo Su, PhD, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: “We are pleased to have successfully completed our first multiregional clinical trial, FRESCO-2, to support the global registration of fruquintinib. It has already benefited patients with advanced colorectal cancer in China since its launch in 2018. It is also being evaluated alone and in combination with other agents in various tumor types in ongoing studies around the world.”
HUTCHMED retains all commercial rights to fruquintinib outside of China. Fruquintinib is not approved for use outside of China.