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Treatment of relapsed-refractory (R/R) FLT3 mut AML is an unmet need. Use of gilteritinib monotherapy in the ADMIRAL trial resulted in a modest prolongation of overall survival (OS) from 5.6 months to 9.3 months 1 . Following the results from in-vitro studies showing synergism between gilteritinib and venetoclax 2 , 3 , this combination was studied in a phase Ib/II study, resulting in a median OS of 10.0 months 4 . The combination of gilteritinib with azacytidine-venetoclax in another phase I/II study resulted in a median OS of 5.8 months in the R/R cohort 5 . Thus, even though combination therapy shows improved response rates, cross trial comparisons show the survival with combination therapy to be similar to that of monotherapy at the cost of increased toxicities 1 , 4 , 5 . Thus, clinical equipoise persists regarding the optimal regimen for R/R FLT3 mutated AML. To address this knowledge gap, we conducted a single center retrospective study to evaluate our experience with use of gilteritinib-based therapy in the R/R FLT3 mut AML population. Specifically, we compared the outcomes of patients who received gilteritinib monotherapy with gilteritinib combination therapy.
Rajendra et al. (Tue,) studied this question.
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