HUTCHMED and Takeda Announce Publication of FRESCO-2 Phase III Trial Results for Fruquintinib in The Lancet

HUTCHMED (00013) and Takeda jointly announced that the results of the FRESCO-2 Phase III study of fruquintinib in the treatment of previously treated metastatic colorectal cancer have been published in The Lancet.

This article provides detailed information on the results of the FRESCO-2 study as of June 24, 2022. The summary results as of the data cutoff date were announced on September 12, 2022, at the European Society for Medical Oncology (ESMO) 2022 Annual Meeting.

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3. The FRESCO-2 study is a global Phase III multicenter clinical trial (MRCT) conducted in the United States, Europe, Japan, and Australia, aiming to explore fruquintinib combined with best supportive care versus placebo combined with best supportive care for the treatment of previously treated patients with metastatic colorectal cancer. The FRESCO-2 study met its primary endpoint and key secondary endpoints, showing that fruquintinib treatment achieved statistically significant and clinically meaningful improvements in both overall survival (OS) and progression-free survival (PFS). The safety profile of fruquintinib in the FRESCO-2 study was consistent with the known profile reported in previous fruquintinib clinical trials.

FRESCO-2, as one of the pivotal studies, supported the regulatory submission of fruquintinib to the U.S. Food and Drug Administration (FDA) for the treatment of previously treated metastatic colorectal cancer, which was accepted by the FDA in May 2023 and granted Priority Review. The marketing authorization application to the European Medicines Agency (EMA), as well as the new drug application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA), is planned to be completed in 2023.

In March 2023, HUTCHMED and Takeda reached an exclusive licensing agreement to further advance the global development, commercialization, and production of fruquintinib outside of China.