Azacitidine-Venetoclax or Induction Chemotherapy for Acute Myeloid Leukemia.
N Engl J MedSep 3, 2026
Amir T Fathi, Alexander E Perl, Geoffrey G Fell et al.
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In 30 seconds
This phase 2 randomized trial compared azacitidine plus venetoclax to induction chemotherapy in 172 previously untreated adults with acute myeloid leukemia (AML) eligible for induction. The study found that the median event-free survival was significantly longer in the azacitidine-venetoclax group at 14.5 months compared to 6.2 months in the induction chemotherapy group (hazard ratio 0.57, P=0.002).
Key findings
- Median event-free survival was 14.5 months for azacitidine-venetoclax vs 6.2 months for induction chemotherapy.
- Hazard ratio for event or death was 0.57 (95% CI, 0.39 to 0.84; P=0.002).
- Grade 3 or higher infections occurred in 28% of the azacitidine-venetoclax group vs 41% in the chemotherapy group.
- Grade 3 or higher hemorrhage occurred in 2% of the azacitidine-venetoclax group vs 12% in the chemotherapy group.
Why it matters
The findings suggest that azacitidine-venetoclax may offer a more effective treatment option with a better safety profile for induction-eligible patients with AML, potentially changing standard treatment approaches.