ASH 2025 | Understanding the results of MORPHO: gilteritinib as post-transplant maintenance for FLT3-ITD AML

Long title and kind of a complicated topic. We ran a study called the MORPHO study, which is a randomized study of gilteritinib versus placebo as post-transplant maintenance for FLT3 ITD AML in first remission. And crashing failure to some because it was not positive. I found the trial quite helpful because, in fact, it explained quite a lot about how to use the drug. Patients who had MRD pre- or post-transplant were the ones who benefited from it. But why wasn’t it more positive compared to some other prior trials? And this is a post-hoc analysis of the data and I think it explains why. The trial took place when FLT3 inhibitors were not widely approved. They were approved in the US and Germany and nowhere else. And so in the rest of the world, which is 50% of the trial, patients who had to be in first remission to get on the study were getting treatment without FLT3 inhibitors and were relapsing. They’re not allowed to go on the study. So you have a very selected population in the rest of the world going on this study. Patients who also were taking much longer to go to transplant, which is the practice in many parts of the world. So you have half the study came from the U.S. and Germany where patients got FLT3 inhibitors, went into remission, and immediately went to transplant. And the other half of the study was patients who were out six, seven, eight months from diagnosis and no FLT3 inhibitors, a very selected population that probably didn’t need transplant and certainly didn’t need post-transplant gilteritinib. So we had a population that really wouldn’t benefit and a population that would and MRD actually can distinguish the two as well. So that data is to explain why the trial wasn’t positive like everybody expected.

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