V-FAST Master Trial   

Researchers with John Theurer Cancer Center at Hackensack University Medical Center Publish V-FAST Trial Outcomes

Outcomes with CPX-351 plus Midostaurin in adults with newly diagnosed acute myeloid leukemia by FLT3 mutation type

V-Fast Master Trial

Results of the V-FAST (Vyxeos - First Phase Assessment with Targeted Agents) trial published in Blood offer a subgroup analysis of outcomes with CPX-351 plus Midostaurin (MID) in adults with newly diagnosed acute myeloid leukemia by FLT3 mutation type. A few key findings of this research out of John Theurer Cancer Center at Hackensack University Medical Center:

  • Complete remission (CR) was achieved by 82% patients with a FLT3 ITD mutation and by 83% patients with a FLT3 TKD mutation.
  • Preliminary results suggest the combination of CPX-351 + MID is feasible, with a manageable safety profile and promising remission rates in adults with newly diagnosed, FLT3-mutated AML.
  • Among patients in complete remission and with a measurable residual disease (MRD) assessment, MRD negativity was achieved in 50% of patients with a FLT3 ITD mutation and 33% of patients with a FLT3 TKD mutation after the first induction cycle.

V-FAST is an open-label, multicenter, multi-arm, nonrandomized, phase 1b master trial to evaluate the safety and preliminary efficacy of CPX-351 combined with targeted agents (MID, venetoclax, enasidenib). Eligible adults in the CPX-351 + MID cohort were aged 18 to 75 years, had newly diagnosed AML (de novo AML or secondary AML) with a FLT3 mutation, were fit for intensive chemotherapy and had an ECOG performance status of 0 to 2.

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