Fruquintinib significantly extends survival in refractory metastatic colorectal cancer
July 2023
Fruquintinib is a small molecule inhibitor of the vascular endothelial growth factor receptors(VEGFs). VEGFs are involved in the growth and proliferation of endothelial cells, which are needed for the growth of blood vessels that tumour cells require to grow and proliferate.
A recent study published in The Lancet found that treatment with the targeted therapy Fruquintinib resulted in a significant and clinically meaningful survival benefit for patients with refractory metastatic colorectal cancer (cancer that does not respond to treatment).
The phase 3 FRESCO-2 study showed that fruquintinib helped to extend median overall survival by approximately 2.6 months in this patient population which has typically poor outcomes and few treatment options available.
The study
691 patients with heavily pretreated mCRC were included in the analysis. Patients had previously received all current standard approved chemotherapies and targeted therapies and had disease progression on or did not tolerate trifluridine/tipiracil (Lonsurf) and/or regorafenib (Stivarga). Lonsurf and Stivarga are two approved therapies used for the treatment of refractory mCRC after all previous standard therapies have failed.
Patients were randomly assigned to received fruquintinib or an oral placebo, in addition to best supportive care.
Best supportive care: treatment that is focused on managing symptoms and helping to keep the patient as well as possible.
Why does this study use a placebo?
While placebos are not commonly used in cancer clinical trials, this trial included placebo because this patient population had no additional approved treatment options available to them beyond best supportive care.
The Study’s Results
Median overall survival was 2.6 months longer in the fruquintinib arm compared to placebo and best supportive care. Grade 3 or worse adverse events occurred in 63% of patients who received fruquintinib compared to 50% of patients who received placebo. Quality of life data will continue to be analysed from the trial.
Conclusion
Fruquintinib resulted in a significant and clinically meaningful benefit to overall survival compared to placebo in patients with refractory mCRC and represents a potential new treatment option for patients in this setting. Though the 2.6-month median overall survival improvement is modest, it remains meaningful in a heavily pretreated patient population compared to other approved therapies with similar phase III designs in the same disease setting. Ongoing analysis of quality of life data will further characterize the clinical benefit of this targeted therapy in this patient population.
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