# VIALE-A

Source: https://onco.cc/trials/viale-a/  
OnCo record `viale-a` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02993523
- Phase: 3
- Setting: Newly diagnosed AML unfit for intensive chemotherapy: venetoclax + azacitidine vs placebo + azacitidine
- Sponsor: AbbVie / Genentech
- Enrolled: 443
- Result: OS 14.7 vs 9.6 months, HR 0.66; CR 36.7% vs 17.9%.
- Outcomes: Overall survival (median): Venetoclax + azacitidine 14.7 months vs Placebo + azacitidine 9.6 months, HR 0.66; Complete remission: Venetoclax + azacitidine 36.7% vs Placebo + azacitidine 17.9%; Composite CR (CR + CRi): Venetoclax + azacitidine 66.4% vs Placebo + azacitidine 28.3%
- 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.

## Sources

- ClinicalTrials.gov NCT02993523: https://clinicaltrials.gov/study/NCT02993523
- NEJM 2020: https://www.nejm.org/doi/full/10.1056/NEJMoa2012971

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Acute myeloid leukaemia in older or unfit patients](https://onco.cc/cancers/aml-older-unfit/), [FLT3-mutated acute myeloid leukaemia](https://onco.cc/cancers/aml-flt3/), [IDH1- and IDH2-mutated acute myeloid leukaemia](https://onco.cc/cancers/aml-idh/), [NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia](https://onco.cc/cancers/aml-npm1-kmt2a/), [Secondary and therapy-related acute myeloid leukaemia](https://onco.cc/cancers/aml-secondary/)
- technologies: [BCL-2 inhibitors](https://onco.cc/technologies/bcl2-inhibitors/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BCL-2](https://onco.cc/targets/bcl2/)
- drugs: [Azacitidine](https://onco.cc/drugs/azacitidine/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- companies: [AbbVie (incl. ImmunoGen, Capstan)](https://onco.cc/companies/abbvie/), [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- pathways: [Intrinsic apoptosis (BCL-2 family)](https://onco.cc/pathways/apoptosis-bcl2/)
- terms: [Tumour lysis syndrome (TLS)](https://onco.cc/terms/tumor-lysis-syndrome/)
- people: [Courtney D. DiNardo](https://onco.cc/people/courtney-dinardo/)
- pairings: [Venetoclax + hypomethylating agent](https://onco.cc/pairings/venetoclax-plus-hma/)
- ideas: [Shorter venetoclax courses in unfit AML](https://onco.cc/ideas/idea-shortened-venetoclax/)
- bottlenecks: [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/)
- key papers: [VIALE-A: venetoclax plus azacitidine for older adults with acute myeloid leukaemia who cannot have intensive chemotherapy](https://onco.cc/key-papers/paper-viale-a-venetoclax-azacitidine-nejm-2020/)
- roadmaps: [Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome](https://onco.cc/roadmaps/epigenetics-roadmap/)

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