EHA 2023 | LBA: gilteritinib as post-transplant maintenance therapy in FLT3-ITD AML
Mark Levis, MD, PhD, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, shares the results of the BTM-CTN 1506 (MORPHO; NCT02997202) Phase III study evaluating gilteritinib as a post-transplant maintenance therapy for patients with acute myeloid leukemia (AML) carrying an internal tandem duplication mutation of FLT3 (FLT3-ITD). Whilst the study did not show a benefit for gilteritinib in all patients, its positive effect was more pronounced in patients who were measurable residual disease (MRD)-positive before allogeneic transplantation. This interview took place at the 28th Congress of the European Hematology Association (EHA) 2023 in Frankfurt, Germany.
These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.
Transcript (edited for clarity)
The MORPHO trial, the way we designed it, was to tell us how to use a FLT3 inhibitor, and in whom, in the post-transplant setting. We were actually called, by some, unethical for running a randomized placebo-controlled trial of a FLT3 inhibitor post-transplant because many in the world thought it was a settled issue. But in fact, the trial was negative, in that it did not provide benefit to all patients who are undergoing allotransplant...
The MORPHO trial, the way we designed it, was to tell us how to use a FLT3 inhibitor, and in whom, in the post-transplant setting. We were actually called, by some, unethical for running a randomized placebo-controlled trial of a FLT3 inhibitor post-transplant because many in the world thought it was a settled issue. But in fact, the trial was negative, in that it did not provide benefit to all patients who are undergoing allotransplant. Fortunately, we had an underlying hypothesis that we could identify who would benefit and that we would use a very sensitive, specifically designed MRD assay to identify those patients. And that aspect worked perfectly. 50% of the patients in the study had detectable MRD in the peri-transplant period, and those were patients that displayed a very distinct benefit to the use of gilteritinib.
So not only have we learned that, in fact, no, not everybody benefits from a FLT3 inhibitor after allotransplant. We know how to identify those patients who do. And we are going to learn about how to mitigate any potential toxicities of FLT3 inhibitors from the trial, I think. And finally, we have uncovered or demonstrated the utility of MRD in managing these patients, including in the non-allotransplant setting.
Read more...
