{"entity":{"id":"fresco-2","kind":"trial","name":"FRESCO-2","aka":[],"tldr":"A selective VEGF-receptor pill gave a modest but real survival gain in patients with no remaining standard treatment.","summary":"FRESCO-2, trial NCT04322539 sponsored by Hutchmed and Takeda and published in the Lancet in 2023, showed that the selective VEGF receptor tablet fruquintinib gives a modest but real survival gain in metastatic colorectal cancer patients with no remaining standard treatment. It randomised 691 patients after all standard therapies to fruquintinib or placebo, met its primary overall survival endpoint and led to FDA approval in November 2023, with hypertension and hand-foot syndrome the main toxicities and better tolerability than regorafenib. OnCo links it to colorectal cancer, VEGF as a target, fruquintinib, Jin Li and Tae Won Kim, and it replicates the Chinese FRESCO trial. How fruquintinib should be ordered against trifluridine and tipiracil plus bevacizumab is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04322539","url":"https://clinicaltrials.gov/study/NCT04322539"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":["vegf"],"drugs":["fruquintinib"],"companies":["hutchmed","takeda"],"institutions":[],"pathways":[],"terms":[],"trials":["fresco","correct","concur"],"people":["li-jin-fuscc","kim-tae-won"],"bottlenecks":[],"keyPapers":["paper-dasari-fresco-2-fruquintinib-lancet-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04322539","phase":"3","setting":"Refractory metastatic colorectal cancer after all standard therapies: fruquintinib vs placebo","sponsor":"HUTCHMED / Takeda","result":"OS 7.4 vs 4.8 months, HR 0.66.","started":"2020-08-12","startedType":"actual","yearReported":2023,"enrolled":691,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Fruquintinib","n":461,"value":7.4},{"name":"Placebo","n":230,"value":4.8}],"hr":0.66,"ci":[0.55,0.8],"source":"https://www.takedaoncology.com/newsroom/news-releases/2023/hutchmed-fresco2-lancet-results/"}],"replication":"Replicates the Chinese FRESCO trial (OS 9.3 vs 6.6 months)."},"route":"/trials/fresco-2/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"kras-g12c-colorectal","kind":"cancer","name":"KRAS G12C-mutant colorectal cancer","route":"/cancers/kras-g12c-colorectal/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"fruquintinib","kind":"drug","name":"Fruquintinib","route":"/drugs/fruquintinib/"}],"company":[{"id":"hutchmed","kind":"company","name":"Hutchmed","route":"/companies/hutchmed/"},{"id":"takeda","kind":"company","name":"Takeda","route":"/companies/takeda/"}],"trial":[{"id":"concur","kind":"trial","name":"CONCUR","route":"/trials/concur/"},{"id":"correct","kind":"trial","name":"CORRECT","route":"/trials/correct/"},{"id":"fresco","kind":"trial","name":"FRESCO","route":"/trials/fresco/"}],"person":[{"id":"li-jin-fuscc","kind":"person","name":"Jin Li","route":"/people/li-jin-fuscc/"},{"id":"kim-tae-won","kind":"person","name":"Tae Won Kim","route":"/people/kim-tae-won/"}],"paper":[{"id":"paper-dasari-fresco-2-fruquintinib-lancet-2023","kind":"paper","name":"Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2)","route":"/key-papers/paper-dasari-fresco-2-fruquintinib-lancet-2023/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"}]}}