PARADIGM
Phase 2Practice-changingMed onc

Population. Newly diagnosed fit adults with AML, excluding FLT3, core-binding factor, and younger NPM1-mutated disease
Arms. Induction chemotherapy vs Azacitidine plus venetoclax
Endpoint: Event-free survival
Phase 2, n=172. Event-free survival was 6.2 months with induction and 14.5 months with azacitidine-venetoclax (HR 0.57, 95% CI 0.39 to 0.84, p=0.002). Grade 3 or higher infection was 41% vs 28%.
Takeaway. A randomized signal that azacitidine-venetoclax can beat intensive induction on event-free survival in fit adults, still phase 2 rather than a registrational phase 3. A systemic induction choice for fit adults with AML.

























