Phase III results of fruquintinib in refractory patients with mCRC

Colorectal cancer (CRC) is the third most common, with metastasis being the major cause of death in the majority of patients. Common sites of distant metastasis are the liver and the peritoneum. CRC starts in the colon or the rectum. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. The drug is designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability, and provide more consistent target coverage. Patients with refractory metastatic colorectal cancer have very limited treatment possibilities and poor outcomes.

In the fruquintinib group, the median OS was 7.4 months. Among the placebo group, the median OS was 4.8 months. Among fruquintinib patients, the DCR was also more than 3 times higher than the placebo group as well. Patients showed statistically significant improvement on the secondary endpoint of PFS as well. The median PFS was 3.7 months for fruquintinib, more than double the PFS of the placebo group (1.8 months). It is a selective, potent oral vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 inhibitor that was designed to improve kinase selectivity. VEGFR inhibitors are important to prevent tumor growth from angiogenesis, which occurs when new blood vessels form. This formation process can proliferate the growth of new cancer tissue, helping it to spread to other parts of the body. Fruquintinib can help to minimize off-target toxicities, improve tolerability, and provide consistent target coverage. In the FRESCO-2 study, fruquintinib showed a consistent safety profile with prior study data. Among patients, 62.7% had grade 3 or higher adverse events (AEs), which was 12.3% more than the placebo group. The most common AEs were hypertension, asthenia, and hand-foot syndrome.

Conclusion- Fruquintinib was well tolerated with a safety profile consistent with the previously established monotherapy profile. The FRESCO-2 results are consistent with those of FRESCO and support new global oral treatment options for patients with refractory mCRC, which enriches the continuum of care for these patients. OS and PFS improvement was consistent across all pre-specified subgroups. And the company aims to apply for marketing authorization with the US FDA, the EMA, and the PMDA.

Expert Opinion: “This study supports the meaningful survival improvement and manageable safety profile of fruquintinib”

“As this is a well-tolerated treatment, and given the consistency of the results in both trials, this may very possibly be a promising opportunity for patients with metastatic colorectal cancer”

Get more detailed insights: Metastatic Colorectal Cancer Market, Colorectal Cancer Market