Hutchmed, Takeda publish phase 3 results of Fresco-2 trial in The Lancet

Takeda (TAK) and HUTCHMED (HCM) announced that results of the Phase 3 FRESCO2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer were published in The Lancet. The publication provides details of the FRESCO-2 study results as of June 24, 2022. Summary results from this cut-off date were presented on September 12, 2022, at the European Society for Medical Oncology Congress 2022. Fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors -1, -2 and -3. FRESCO-2 is a global Phase 3 multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care vs placebo plus BSC in patients with previously treated metastatic CRC. The FRESCO-2 study met its primary and key secondary endpoints, demonstrating that treatment with fruquintinib resulted in a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival, respectively. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported fruquintinib studies. FRESCO-2 was a key study supporting regulatory submissions to the U.S. Food and Drug Administration and to the European Medicines Agency for fruquintinib for the treatment of previously treated metastatic CRC. The FDA granted Priority Review to the New Drug Application (NDA) in May of 2023 and the EMA validated the Marketing Authorization Application for review in June of 2023. An NDA to the Japan Pharmaceuticals and Medical Devices Agency is also planned in 2023.