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Although the treatment of leukemia is improving, about 50% of patients with acute myeloid leukemia (AML) do not respond to induced treatment (primary induction failure, PIF) or relapse within 6 months of induced remission (early recurrence, ER).
recently, Uy Geoffrey L et al. have found that immuno-immersive tumor microenceptogenes (TME) is associated with resistance to drug resistance to glycosine-based chemotherapy, as well as to the response to dual-specific DART antibodies targeting CD3 and CD123.
this is a multi-center, open-label, Phase 1/2 clinical trial designed to assess the efficacy and safety of flotetuzumab in adult patients with relapsed/refrive AML.
recruited 88 AML patients, 42 entered the dose discovery phase, and 46 received the recommended phase 2 dose (RP2D) and 500 ng/kg days.
the dose and program of Fletuzumab is consistent with the mode of action of fletuzumab, the most common adverse event is infusion-related reaction (IRR)/cytokine release syndrome (CRS), mostly level 1-2.
the rapid use of toad monoantigen and temporary reduction/disruption doses in week 1 successfully prevented severe IRR/CRS and achieved acceptable tolerance.
patients with immuno-immersive TME with PIC/ER AML, clinical benefits increased.
30 PF/ER patients treated with RP2D were treated with remission, with a CR/CRH rate of 26.7% and a total efficiency (CR/CRH/CRI) of 30.0%.
OS was 10.2 months (1.87 to 27.27), and the survival rates for 6 months and 12 months were 75% (95% CI, 0.450 to 1.05) and 50% (95% CI, 0.154 to 0.846), respectively.
bone marrow transcription analysis of the 10 genes most relevant to the flotetuzumab response showed that a simple 10 gene characteristics could predict the patient's complete response to flotetuzumab (AUROC=0.904, compared to the ELN risk classifier of 0.672).
, Floteuzumab represents an innovative experimental approach related to acceptable safety and encouraging evidence of activity in patients with PF/ER AML.
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