ASH

ASH 2025: Drug combo outperforms standard chemotherapy in AML patients

December 11, 2025

In the phase 2 PARADIGM trial (N = 172), azacitidine plus venetoclax (aza-ven) significantly extended event-free survival (EFS) (median >14 months vs. ~6 months) compared with standard induction chemotherapy in newly diagnosed, fit adults with intermediate-to-high-risk acute myeloid leukemia (AML). One-year EFS was 53% for aza-ven vs. 36% for chemotherapy. Aza-ven also achieved higher overall response (88% vs 62%) and composite complete response rates (78% vs 54%), with more patients proceeding to transplant (61% vs. 40%). Early mortality was 0% with aza-ven vs. 5% for chemotherapy, and patients reported better quality of life and fewer ICU admissions.

Clinical takeaway: Aza-ven may offer a safer, more effective frontline alternative for fit AML patients, improving remission, transplant readiness, and quality of life.

Source:

Fathi A, et al. “Results from PARADIGM — a phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia.” Presented: 67^th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7, 2025; Orlando, FL. Accessed December 10, 2025. https://meetings-api.hematology.org/api/abstract/vmpreview/296881