The FRESCO-2 trial: exploring treatment options for patients with metastatic colorectal cancer

Findings from the global FRESCO-2 trial showed that a drug called fruquintinib (fru-kin-tih-nib) significantly improved overall survival and progression-free survival in patients with metastatic colorectal cancer that has stopped responding to treatment (also known as refractory metastatic colorectal cancer). The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2022 held earlier this month in Paris, France.

Refractory metastatic colorectal cancer: colorectal cancer that no longer responds to treatment.

These findings are encouraging, as patients who develop refractory metastatic colorectal cancer have limited treatment options and poor outcomes. As such, there is a high unmet need for treatment alternatives once current standard therapies fail. With fruquintinib, patients with refractory disease may have a new treatment opportunity.

What is fruquintinib?

Fruquintinib is a highly potent inhibitor of the vascular endothelial growth factor (VEGF) receptors found on the surface of cells. VEGF receptors are involved in a process known as angiogenesis or the development of new blood vessels. New blood vessels are essential to tumour growth, development and metastasis, therefore blocking or inhibiting the VEGF receptor is an important target in the treatment of cancer.

In the original phase III FRESCO-2 study, fruquintinib was given as third-line therapy or later to patients with metastatic colorectal cancer. It led to improvements in average overall survival among patients, which led to the drug’s approval in China in 2018 and in the US in 2020, where the US Food and Drug Administration granted a fast-track approval to fruquintinib to treat some patients with colorectal cancer who had already received previous therapies.

The study

Patients with metastatic colorectal cancer were eligible to join the trial if they were previously treated with chemotherapy, targeted therapies such as anti-VEGF therapy (anti-angiogenesis drugs such as bevacizumab), TAS-102 (Lonsurf), regorafenib, or immune checkpoint inhibitors (immunotherapy).

Patients who were treated with fruquintinib had statistically significant improvements to their overall survival, which was prolonged to 7.4 months compared to patients who received best supportive care alone. Patients also experienced statistically significant improvements to their median progression-free survival, which was 3.7 months compared to 1.8 months among patients who received best supportive care alone. Overall, patients who received the new drug had a 34% reduction in the risk of death.

Best supportive care: consists of appropriate palliative care without any other anticancer therapies. It includes physical, psychological, social, and spiritual support.

Conclusions

The FRESCO-2 study demonstrates meaningful survival improvement and a manageable safety profile associated with fruquintinib. The study investigators are in the process of assessing quality of life data from the study participants. Future studies will be dedicated to exploring fruquintinib in combination with other therapies for patients with colorectal cancer.