VIALE-A
In newly diagnosed AML unsuitable for intensive induction, does venetoclax plus azacitidine improve survival over azacitidine alone?
One underlying study; aliases and follow-up reports consolidated. Primary discipline: Medical.
431 patients with newly diagnosed AML ineligible for intensive induction because of age or comorbidity.
Newly diagnosed AML unsuitable for intensive chemotherapy; not a comparison against intensive induction in fit patients.
431 randomised/evaluable as reported.
Venetoclax daily with ramp-up plus azacitidine 75 mg/m² days 1–7 of each 28-day cycle.
Placebo plus azacitidine on the same schedule.
Endpoints and results
Primary OS; remission, response duration and safety secondary.
- Median OS 14.7 vs 9.6 months; HR 0.66 (95% CI 0.52–0.85; p<0.001).
- CR/CRi 66.4% vs 28.3%.
- Grade 3–4 febrile neutropenia 42% vs 19%; serious AEs 83% vs 73%.
- AEs led to permanent venetoclax discontinuation in 24%.
Absolute Effect and outcome visualisation
Median OS
months (median, not fixed-time rate) · Primary OS analysis. Bars compare reported medians only; they are not fixed-time survival probabilities.
Interpretation: No fixed-time OS rates reproduced here; NNT not calculated from median OS.
Toxicity, discontinuation and quality of life
Trial-specific harms: Prolonged cytopenias, febrile neutropenia and infection; grade 3–4 febrile neutropenia 42% vs 19%.
Treatment burden/discontinuation: Permanent venetoclax discontinuation due to AEs 24%; frequent marrow assessment, dose holds and cycle delays.
Quality of life: No numerical comparative QoL estimate asserted here.
Subgroups, maturity and limitations
Subgroups: Molecular risk and remission depth inform prognosis; population is specifically unfit for intensive induction.
Maturity: Phase III primary report 2020; later follow-up and molecular analyses exist.
Limitations: Control was azacitidine alone, not intensive chemotherapy. Cytopenia management and infection prevention are essential.
VIALE-A established venetoclax plus azacitidine for AML patients unfit for intensive induction, improving OS/remission but increasing myelosuppression and management burden.
Use current regional guidelines, patient fitness, biomarkers, competing risks, alternatives and regulatory status before clinical application. Clinical freshness review and browser-rendered QA remain pending.
Primary sources and registry
Registry: NCT02993523
The Absolute Effect · Updated 26 October 2026 · Never derive NNT from median survival.