Dr Levis on Maintenance Gilteritinib After ASCT in FLT3-ITD+ AML

Mark J. Levis, MD, PhD, the program leader of the Hematologic Malignancies and Bone Marrow Transplant Program at Sidney Kimmel Comprehensive Cancer Center, and a professor of Oncology at Johns Hopkins Medicine, discusses data from the phase 3 BMT CTN 1506/MORPHO trial (NCT02997202) of gilteritinib (Xospata) as maintenance therapy following allogeneic stem cell transplant (ASCT) in patients With FLT3-ITD–positive acute myeloid leukemia (AML).

Patients who achieved a morphologic remission following 1 or 2 induction therapies and underwent ASCT were randomly assigned to receive gilteritinib at 120 mg or placebo once per day for 2 years as maintenance therapy. Data presented at the 2023 EHA Congress showed that the study failed to reach its primary end point for relapse-free survival (RFS). Levis says patients in the gilteritinib arms achieved a numerical but not statistically significant improvement in RFS (HR, 0.679; 95% CI, 0.459-1.005; 2-sided P = .0518).

Although a statistically significant improvement in RFS was not observed in the overall population, Levis notes that looking at the RFS effect of gilteritinib vs placebo based on minimal residual disease (MRD) status provides important context. In patients who were MRD positive, gilteritinib (n = 89) led to an improvement in RFS over placebo (n = 91; HR, 0.515; 95% CI, 0.316-0.838; P = .0065). In those who were MRD negative, the RFS curves were similar for gilteritinib (n = 89) and placebo (n = 87; P = .5750).

The MRD data helped identify those patients who could potentially benefit from gilteritinib following ASCT, Levis explains. He explains that there could also be patients classified as MRD negative who could benefit from the use of maintenance gilteritinib.

Since gilteritinib is associated with myelosuppression, monitoring blood counts is important during its administration, Levis says, adding that dose reductions for the agent and adjustments of concomitant medications are necessary to keep patients on treatment.

Data from MORPHO could ultimately help guide the management of patients with FLT3-ITD–positive AML by showing which factors could determine whether those in this patient population could benefit from FLT3 inhibition, Levis concludes.