At ASH 2025, major findings from the PARADIGM trial showed azacitidine (Aza) + venetoclax (Ven) significantly improved event-free survival (EFS), response rates, and tolerability compared to standard intensive chemo for fit, newly diagnosed AML patients, potentially offering a safer, superior frontline option.
In the trial, 172 adult patients were randomly assigned to receive either aza-ven or standard intensive induction chemotherapy. The results were significantly better in the aza-ven arm for the trial’s primary endpoint, event-free survival (EFS), with events defined as relapse, disease progression, disease refractoriness prompting change in therapy, or death. The effect of aza-ven remained protective even after adjusting for other variables, and at one year, 53% of those in the aza-ven arm met criteria for EFS compared with 36% of those in the control arm