{"entity":{"id":"viale-a","kind":"trial","name":"VIALE-A","aka":[],"tldr":"The trial that gave older AML patients a real treatment: adding venetoclax to azacitidine doubled remission rates and extended survival.","summary":"Median OS 14.7 vs 9.6 months (HR 0.66, 95% CI 0.52-0.85); composite CR 66.4% vs 28.3%; CR 36.7% vs 17.9%. Benefit across IDH1/2 (OS HR 0.35) and NPM1 subgroups; less in FLT3-ITD and TP53. Long-term follow-up (2022): 24-month OS 37.5% vs 16.7%. NEJM 2020. Became the global standard for unfit AML and the backbone for triplet trials.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02993523","url":"https://clinicaltrials.gov/study/NCT02993523"},{"label":"NEJM 2020","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2012971"}],"tags":[],"related":[],"cancers":["aml","aml-older-unfit"],"sections":[],"technologies":["bcl2-inhibitors","kinase-inhibitors"],"targets":["bcl2"],"drugs":["venetoclax","azacitidine"],"companies":["abbvie","roche-genentech"],"institutions":[],"pathways":["apoptosis-bcl2"],"terms":["tumor-lysis-syndrome"],"trials":[],"people":["courtney-dinardo"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02993523","phase":"3","setting":"Newly diagnosed AML unfit for intensive chemotherapy: venetoclax + azacitidine vs placebo + azacitidine","sponsor":"AbbVie / Genentech","result":"OS 14.7 vs 9.6 months, HR 0.66; CR 36.7% vs 17.9%.","started":"2017-02-02","startedType":"actual","yearReported":2020,"enrolled":443,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Venetoclax + azacitidine","n":286,"value":14.7},{"name":"Placebo + azacitidine","n":145,"value":9.6}],"hr":0.66,"ci":[0.52,0.85],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2012971"},{"endpoint":"Complete remission","primary":true,"unit":"%","arms":[{"name":"Venetoclax + azacitidine","value":36.7},{"name":"Placebo + azacitidine","value":17.9}],"source":"https://doi.org/10.1056/NEJMoa2012971"},{"endpoint":"Composite CR (CR + CRi)","unit":"%","arms":[{"name":"Venetoclax + azacitidine","value":66.4},{"name":"Placebo + azacitidine","value":28.3}],"source":"https://doi.org/10.1056/NEJMoa2012971"}],"replication":"VIALE-C (venetoclax + low-dose cytarabine) showed a consistent but initially non-significant OS trend; large real-world series (US, Europe, Asia) reproduce ~60% composite CR and 11-15 month median OS."},"route":"/trials/viale-a/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-older-unfit","kind":"cancer","name":"Acute myeloid leukaemia in older or unfit patients","route":"/cancers/aml-older-unfit/"},{"id":"aml-flt3","kind":"cancer","name":"FLT3-mutated acute myeloid leukaemia","route":"/cancers/aml-flt3/"},{"id":"aml-idh","kind":"cancer","name":"IDH1- and IDH2-mutated acute myeloid leukaemia","route":"/cancers/aml-idh/"},{"id":"aml-npm1-kmt2a","kind":"cancer","name":"NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia","route":"/cancers/aml-npm1-kmt2a/"},{"id":"aml-secondary","kind":"cancer","name":"Secondary and therapy-related acute myeloid leukaemia","route":"/cancers/aml-secondary/"}],"technology":[{"id":"bcl2-inhibitors","kind":"technology","name":"BCL-2 inhibitors","route":"/technologies/bcl2-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"bcl2","kind":"target","name":"BCL-2","route":"/targets/bcl2/"}],"drug":[{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"pathway":[{"id":"apoptosis-bcl2","kind":"pathway","name":"Intrinsic apoptosis (BCL-2 family)","route":"/pathways/apoptosis-bcl2/"}],"term":[{"id":"tumor-lysis-syndrome","kind":"term","name":"Tumour lysis syndrome (TLS)","route":"/terms/tumor-lysis-syndrome/"}],"person":[{"id":"courtney-dinardo","kind":"person","name":"Courtney D. DiNardo","route":"/people/courtney-dinardo/"}],"pairing":[{"id":"venetoclax-plus-hma","kind":"pairing","name":"Venetoclax + hypomethylating agent","route":"/pairings/venetoclax-plus-hma/"}],"idea":[{"id":"idea-shortened-venetoclax","kind":"idea","name":"Shorter venetoclax courses in unfit AML","route":"/ideas/idea-shortened-venetoclax/"}],"bottleneck":[{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"}],"paper":[{"id":"paper-viale-a-venetoclax-azacitidine-nejm-2020","kind":"paper","name":"VIALE-A: venetoclax plus azacitidine for older adults with acute myeloid leukaemia who cannot have intensive chemotherapy","route":"/key-papers/paper-viale-a-venetoclax-azacitidine-nejm-2020/"}],"roadmap":[{"id":"epigenetics-roadmap","kind":"roadmap","name":"Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome","route":"/roadmaps/epigenetics-roadmap/"}]}}