Study summary

A gentler pill-and-injection regimen beat intensive chemotherapy for fit patients

PARADIGM trial · 172 people, randomized phase 2 · Published September 2026, New England Journal of Medicine

What was tested

Azacitidine plus venetoclax, a lower-intensity regimen, against standard intensive induction chemotherapy, for adults with newly diagnosed AML who were fit enough for intensive chemo (mostly higher-risk disease).

What they found

• Median event-free survival was 14.5 vs 6.2 months.
• Serious infections (28% vs 41%) and bleeding (2% vs 12%) were less common.
• 72% had adverse-risk disease; people with FLT3 or most NPM1 mutations were excluded.

What it means

Challenges the default of intensive chemotherapy for fit adults with higher-risk AML; larger trials will need to confirm it.