Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib, an oral VEGFR-1/2/3 inhibitor used for metastatic colorectal cancer (mCRC). Researchers conducted a concentration-QTc (C-QTc) analysis using data from the phase III FRESCO-2 trial, which included 205 patients (137 on fruquintinib, 68 on placebo). By modeling the relationship between drug/metabolite concentrations and QT interval changes on ECGs, the study aimed to determine whether fruquintinib prolongs the QTc interval—a marker of potential heart rhythm risk.

The results showed no clinically significant QTc prolongation, even at peak or double the steady-state exposure of fruquintinib’s primary metabolite (M11). The upper bound of the 90% confidence interval for QTc changes remained well below the regulatory threshold of concern (10 ms). These findings suggest that fruquintinib, at approved dosing levels, does not pose a meaningful risk to cardiac repolarization, supporting its safe use in patients with heavily pretreated mCRC.