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ASH 2025 | Crenolanib plus salvage chemotherapy in FLT3-mutant R/R AML: results from a randomized trial
Thomas Cluzeau, MD, PhD, Central University Hospital of Nice, Nice, France, discusses the results of a randomized, placebo-controlled, double-blind trial (NCT03250338; EudraCT 2017-001600-29) evaluating crenolanib in combination with salvage chemotherapy in patients with FLT3-mutant relapsed/refractory (R/R) acute myeloid leukemia (AML). Dr Cluzeau highlights that the study met its primary endpoint, demonstrating a statistically significant improvement in event-free survival (EFS) in the crenolanib arm. Notably, the benefit of crenolimab treatment was most pronounced in patients with NPM1 co-mutated disease. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So during the ASH meeting, it was a pleasure for me to present the results of the RO013 study. So this is a study evaluating Crenolanib in combination with salvage chemo in patients with FLT3 mutated and relapsed/refractory acute myeloid leukemia. So in vitro analysis, we identified that Crenolanib has a high sensitivity for FLT3-ITD patients, but also for patients co-mutated for NPM1, DNMT3A, and WT1...
So during the ASH meeting, it was a pleasure for me to present the results of the RO013 study. So this is a study evaluating Crenolanib in combination with salvage chemo in patients with FLT3 mutated and relapsed/refractory acute myeloid leukemia. So in vitro analysis, we identified that Crenolanib has a high sensitivity for FLT3-ITD patients, but also for patients co-mutated for NPM1, DNMT3A, and WT1. So we designed this study. So this is a randomized study. So Crenolanib plus salvage chemo versus placebo plus salvage chemo.
So 106 patients were randomized in the study and the results are positive because in terms of response, there is a significant increase of response in the Crenolanib arm. And the primary endpoint of the study was the event-free survival, and we observed a significant increase in terms of event-free survival in the Crenolanib arm. And when we focus on FLT3 and NPM1 mutation, we identify a very big improvement for these patients. There is a better event-free survival and also significant improvement in terms of overall survival in these patients. And when we analyze only transplanted patients, we also observe a benefit of Crenolanib for patients transplanted because patients receive also Crenolanib maintenance after allo stem cell transplantation. And the suggestion is maybe the Crenolanib maintenance has an impact after allo stem cell transplantation. So to conclude, this study is positive. This is the first randomized study to identify benefits of salvage chemo plus TKI in a relapsed/refractory setting. Some development of this drug will be due in the future.
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