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Acute myeloid leukemia (AML) is a highly heterogeneic disease.
although there are now a variety of approved therapeutic drugs, but the cure rate is still poor.
about 50% of patients with acute myeloid leukemia (AML) do not respond to induction therapy (primary induced failure (PIF)) or relapse within 6 months (early recurrence (ER).
This is a multi-center, open-label, 1/2 study that recruited 88 adult relapsed/re treatable AML patients: 42 in the dose exploration queue and 46 in the recommended phase 2 dose (RP2D) queue (500 ng/kg day).
researchers found that the microenviron environment of immuno-immersive tumors was associated with drug resistance to agarose cytosine-based chemotherapy and to flulotetuzumab, a dual-specific DART antibody that targets CD3 and CD123.
the benefits of clinical treatment in patients with immuno-immersive TME.
of the 30 PICF/ER patients treated with the RP2D programme, the rate of complete remission (CR) and CR companion hematological recovery (CRh) was 26.7% and the total efficiency (CR/CRh/CR with incomplete hematology recovery) was 30.0%.
total survival period was 10.2 months (1.87 to 27.27), and the survival rate for 6 months and 12 months was 75% (95% CI 0.450 to 1.05) and 50% (0.154 to 0.846), respectively.
most common adverse events are infusion-related reactions (IRR) and cytokine release syndrome (CRS), mainly level 1-2.
step-by-step dosage, dexamisong pre-treatment, rapid use of toad monoantigen and temporary dose reduction/disruption can successfully prevent the occurrence of severe IRR/CRS.
bone marrow transcription analysis showed that a simple 10 gene signature could predict CRs (AUC-0.904) for fluoroformation bead monoantigen therapy in PIFI/ER patients, with significantly better accuracy than the ELN risk classification.
addition, floteuzumab represents an innovative and experimental treatment that demonstrates acceptable safety and encouraging therapeutic activity in PIF/ER patients.