Analysis of fruquintinib in patients with metastatic colorectal cancer who were enrolled in Spain: results from the global FRESCO-2 study

Background: In the phase III FRESCO-2 study, overall survival (OS) was significantly improved with fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). Here, we present data from a FRESCO-2 subanalysis of patients enrolled in Spain. Patients and methods: In FRESCO-2, patients had received all standard chemotherapies, anti-vascular endothelial growth factor and anti-epidermal growth factor receptor therapies, if indicated, and had progressed on or were intolerant to trifluridine/tipiracil (TAS-102) and/or regorafenib. Patients were randomized 2 : 1 to receive fruquintinib 5 mg orally or matching placebo once daily for 21 days in 28-day cycles, plus BSC. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS), safety, and health-related quality of life. Results: Of the 180 patients enrolled across 16 sites in Spain (26% of the global study population), 116 received fruquintinib and 64 received placebo. Baseline characteristics were balanced between arms. Patients treated with fruquintinib versus placebo had a median OS of 7.6 versus 4.6 months [hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.44-0.91] and a median PFS of 3.7 versus 1.8 months (HR 0.24, 95% CI 0.17-0.36). Grade ≥3 treatment-emergent adverse events were reported in 60% versus 47% of patients treated with fruquintinib versus placebo. Median time to deterioration to an Eastern Cooperative Oncology Group performance status of two or more or death was 5.1 versus 2.9 months (HR 0.59, 95% CI 0.42-0.84) with fruquintinib versus placebo. Conclusions: Results were consistent with the global FRESCO-2 study population, therefore supporting fruquintinib as a new treatment option for patients with refractory mCRC.