ASH 2022 | Assessing FLT3-ITD-specific MRD clearance using a PCR-NGS assay in the QuANTUM-First trial
Mark Levis, MD, PhD, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, discusses the results from a secondary analysis of the QuANTUM-First trial (NCT02668653), in which a PCR-NGS assay was used to assess FLT3-ITD-specific measurable residual disease (MRD) clearance in patients treated with quizartinib. This interview took place at the 64th ASH Annual Meeting and Exposition congress held in New Orleans, LA.
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Transcript (edited for clarity)
So this is a secondary analysis from the QuANTUM-First study, and a key secondary endpoint of the QuANTUM-First study was to determine the percentage of patients who had achieved CR, how many of those had cleared MRD? How many of those were MRD negative? The entire field of AML is shifting its focus onto MRD and different techniques, and A, that is a question of interest, just to start with, can we use MRD in a prospective trial to predict outcome?
But in addition, this is the first use of, I think, a novel approach to detecting MRD...
So this is a secondary analysis from the QuANTUM-First study, and a key secondary endpoint of the QuANTUM-First study was to determine the percentage of patients who had achieved CR, how many of those had cleared MRD? How many of those were MRD negative? The entire field of AML is shifting its focus onto MRD and different techniques, and A, that is a question of interest, just to start with, can we use MRD in a prospective trial to predict outcome?
But in addition, this is the first use of, I think, a novel approach to detecting MRD. It is not flow cytometry-based, which is very challenging in AML, despite all the controversies of who’s in favor or not. This is a very specific test. And I want to stress, it’s not a new test. It was first developed by, I think, Michael Heuser’s group 10 years ago and used by the ALFA group three years later, and used by two other groups a few years later to look at very specific FLT3-ITD specific-MRD.
PCR-NGS, it’s a double assay, and you can actually order the assay from a diagnostic lab right now, and a third-party pair will pay for that, and there are centers, including my own, that are currently using this. This was the first test… This abstract presented the data on the first test of this technology or this approach to MRD in a prospective clinical trial. We’ve just demonstrated that it is associated with better survival and that the specific drug treatment lowers that specific MRD, so it’s a specific effect of the drug. So it’s an important abstract, but just a first step.
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