FRESCO-2

NCT04322539 📎

Regimen

Experimental
Fruquintinib 5 mg QD (3 weeks on/1 week off) + BSC
Control
Placebo + BSC

Population

Metastatic CRC, 3L+, refractory to fluoropyrimidine/oxaliplatin/irinotecan ± anti-VEGF ± anti-EGFR (RAS WT); international including China.

Key finding

3L+ refractory mCRC (post-TAS-102 and/or regorafenib): mOS fruquintinib 7.4 vs placebo 4.8 mo (HR 0.66, 95% CI 0.55-0.80, p<0.0001); mPFS 3.7 vs 1.8 mo (HR 0.32, 95% CI 0.27-0.39, p<0.0001); ORR 1.5% vs 0%; DCR 55.6% vs 16.1%; benefit consistent regardless of prior regorafenib/TAS-102 exposure

Source: PMID 37331369

Timeline

    Guideline citations

    • NCCN Colon (p.46)
    • NCCN Rectal (p.63)