Safety and efficacy of azacitidine for treating MRD in patients with MDS and AML: Long-term findings of RELAZA2

The long-term follow-up results from RELAZA2 (NCT01462578) were presented at the European Hematology Association (EHA) 2024 Hybrid Congress by Kubasch.¹ RELAZA2 is a phase II study evaluating the efficacy and safety of azacitidine in the setting of measurable residual disease (MRD)-triggered preemptive therapy to prevent or delay relapse in patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) after chemotherapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT).¹

The study achieved its primary endpoint, with 63% of patients alive and relapse-free at 6 months.

• Of these patients, 65% achieved a major MRD response (NPM1 ≤1% or CD34 donor chimerism ≥80%) and 51% of those remained alive and relapse-free after a median follow-up of 28.7 months.
• Minor response (NPM1 >1% or CD34 donor chimerism <80% or absence of major response or relapse) was observed in 35% of patients, with 24% of these remaining alive and relapse-free after a median follow-up of 22.8 months.

The long-term findings from the RELAZA2 study indicate that azacitidine, used as MRD-guided preemptive therapy, is safe and effective in preventing or delaying hematological relapse in patients with MDS or AML following conventional chemotherapy or allo-HSCT.

• Further research is needed to explore additional preemptive treatment strategies.