{"entity":{"id":"ascertain-v","kind":"trial","name":"ASCERTAIN-V","aka":[],"tldr":"ASCERTAIN-V is the study behind the first all-oral AML regimen, approved in May 2026.","summary":"ASCERTAIN-V, trial NCT04657081 sponsored by Taiho Oncology and reported in 2026, is the study behind the first all-oral acute myeloid leukaemia regimen, approved in May 2026. OnCo links it to acute myeloid leukaemia, the oral decitabine and cedazuridine record, venetoclax and the pairing of venetoclax with a hypomethylating agent. The remission rate is in line with the venetoclax-azacitidine arm of VIALE-A, supporting equivalence of the oral backbone, but there is no randomised comparison, which is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04657081","url":"https://clinicaltrials.gov/study/NCT04657081"}],"tags":[],"related":[],"cancers":["aml"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":["decitabine-cedazuridine","venetoclax"],"companies":["taiho"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04657081","phase":"1/2","setting":"Newly diagnosed AML unfit for intensive induction: oral decitabine-cedazuridine + venetoclax","sponsor":"Taiho Oncology","result":"CR 41.6%; median time to CR 2 months.","started":"2021-02-09","startedType":"actual","yearReported":2026,"enrolled":101,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete remission","primary":true,"unit":"%","arms":[{"name":"Decitabine-cedazuridine + venetoclax","n":101,"value":41.6}],"source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute"}],"replication":"CR rate is in line with the VIALE-A venetoclax-azacitidine arm (36.7%), supporting equivalence of the oral backbone; no randomised comparison."},"route":"/trials/ascertain-v/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"}],"technology":[{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"}],"drug":[{"id":"decitabine-cedazuridine","kind":"drug","name":"Decitabine + cedazuridine (oral)","route":"/drugs/decitabine-cedazuridine/"},{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"company":[{"id":"taiho","kind":"company","name":"Taiho Pharmaceutical (Otsuka)","route":"/companies/taiho/"}],"pairing":[{"id":"venetoclax-plus-hma","kind":"pairing","name":"Venetoclax + hypomethylating agent","route":"/pairings/venetoclax-plus-hma/"}]}}