Can MRD-guided azacitidine treatment improve outcomes in AML and MDS?

Azacitidine may be an efficacious pre-emptive therapy to prevent or delay haematologic relapse in patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) who displayed MRD-positivity after achieving a first clinical remission, results of the phase 2 RELAZA2 study revealed.

“Patients with AML or MDS who reach clinical remission after receiving disease-specific therapy or transplant are observed until a haematological relapse occurs in common practice,” opened Dr Anne Sophie Kubasch (University of Leipzig, Germany) [1]. “In the phase 2 RELAZA2 study (NCT01462578), we assessed whether azacitidine is efficacious in participants who become MRD positive after reaching clinical remission following conventional chemotherapy or allogeneic transplant.”

All participants without haematological relapse, displaying CD34 donor chimerism < 80% or an NPM1 mutational load >1% were considered MRD positive and eligible for azacitidine treatment. The final analysis included 357 participants, of whom 119 were MRD-positive and 95 were eligible for azacitidine treatment. The median follow-up duration was 22.5 months and the primary endpoint was relapse-free survival at 6 months.

The study’s primary endpoint was reached by 63% of the participants. Of the responders, 65% displayed a major MRD and 35% a minor MRD response. “We observed that a favourable European LeukemiaNet (ELN) risk group, a longer time to last therapy, and a lower MRD level were predictive factors influencing the response to azacitidine therapy. Also, participants with a major MRD response presented with an improved overall survival over non-responders. Finally, 51% of the participants with a major MRD response were alive and relapse-free at the time of the analysis. This compares with 24% of participants with a minor MRD response who were alive and relapse-free. “Our results illustrate the importance of achieving MRD negativity,” commented Dr Kubasch.

In conclusion, azacitidine appeared to be safe and efficacious in preventing or delaying haematological relapse in participants with AML or MDS.

1. Kubasch AS, et al. Azacitidine to treat measurable-residual disease in MDS and AML patients: long-term follow-up results of the RELAZA2 study. S265, EHA congress 2024, 13–16 June, Madrid, Spain.

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Posted on 12 August 2024