ASH 2025 | Maintenance therapy in allografted patients with AML: the MORPHO and AMADEUS trials

I think the pivotal study in this space was the MORPHO trial conducted by the U.S. BMT CTN led by Mark Levis. And that demonstrated in patients with a FLT3 mutation that if they were pre-transplant MRD positive or had peri-transplant MRD positivity, maintenance with gilteritinib significantly improved relapse-free survival. Really important proof of principle that maintenance has a role. So we now have to understand where is the role of maintenance. Firstly, in patients who are FLT3-mutated who don’t have MRD positivity. And interestingly, in MORPHO, there was no survival benefit. In fact, there was just increased toxicity. So I think one could reserve the use of FLT3 inhibitors in that population. And secondly, we’re awaiting the results of studies such as AMADEUS, where we randomized 324 patients to receive post-transplant or related azacitidine CC-486. But I think what we need going forward is well-conducted randomized trials assessing the impact of particular therapies, either pan-leukemic activity agents or particular targeted therapies. The real challenge is to think about the redesign of these studies so that we’re only applying maintenance to patients who have a particular risk of relapse and so I think in that context we should be focusing on patients who are pre-transplant MRD positive or have very adverse genetics. That allows us to refine the design of these studies, make them rather smaller and hopefully more deliverable.

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