Multinational phase 3 trial of fruquintinib versus placebo for refractory metastatic colorectal cancer

There is a paucity of effective systemic therapy options for patients with advanced, chemotherapy-refractory colorectal cancer. The multinational phase 3 FRESCO-2 trial evaluated the efficacy and safety of fruquintinib, a selective and potent oral inhibitor of VEGFR1-3, in patients with heavily pretreated metastatic colorectal cancer (mCRC). The trial found a significant and clinically meaningful benefit in overall survival with fruquintinib versus placebo. Grade 3 or worse adverse events occurred in 63% of patients in the fruquintinib group versus 50% of patients in the placebo group. There was one treatment-related death in each group. The authors conclude that these data support the use of fruquintinib as a treatment option for refractory mCRC.