ASH 2025 | A Phase II trial investigating crenolanib plus salvage chemotherapy in R/R FLT3-mutated AML

So, crenolanib is a new generation FLT3 inhibitor, which is not approved yet, still in clinical trials. And in this study, we were looking again at patients with relapsed/refractory FLT3 mutant disease, most of them having failed induction chemotherapy in the past, plus or minus a FLT3 inhibitor. Patients in this randomized phase two study were receiving either crenolanib or plus standard intensive salvage chemotherapy with FLAG or HAM versus FLAG or HAM alone in this setting. And what we found is that the overall response rates in patients getting the FLT3 inhibitor was markedly improved, about 60% versus 39%. Event-free survival, which had a very strict definition, was improved from zero months to 3.4 months. And in particular, patients who had FLT3 in the presence of an NPM1 mutation, plus or minus DNMT3A, had a statistically significant improvement, not only in response rates, but also in overall survival. And so this was a very active regimen. This is the first FLT3 intensive chemotherapy regimen that has shown efficacy in the relapsed refractory FLT3 population. And so we are encouraged that this could be representing a step forward in the continuum of AML therapy for patients with FLT3 mutant disease.

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