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Safety and efficacy of azacitidine for treating MRD in patients with MDS and AML: Long-term findings of RELAZA2
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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 |
| Key learnings1 |
| At a median follow-up of 22.5 months, 119 out of 357 screened patients were MRD positive, and 95 of them were eligible for azacitidine treatment. |
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The study achieved its primary endpoint, with 63% of patients alive and relapse-free at 6 months.
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| Response was significantly impacted by low MRD level (p = 0.006), time from last treatment (p = 0.035), and favorable European LeukemiaNet (ELN) risk group (p = 0.027). |
| In total, 24 of the 25 long-term responders stopped azacitidine, and the median treatment-free duration after azacitidine was 20.8 months. |
| Median delay of hematological relapse after initial MRD detection among MRD responders was 13.9 months. |
| No new safety concerns were observed and the safety profile was consistent with previous studies. |
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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.
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Approximately what proportion of your patients with FLT3-mutations also have NPM1 and DNMT3A co-mutations?
