Key Data From the BMT CTN 1506/MORPHO Trial of Gilteritinib 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 the key takeaways from the phase 3 BMT CTN 1506/MORPHO trial (NCT02997202) which evaluated maintenance gilteritinib (Xospata) after allogeneic stem cell transplant (ASCT) in patients with FLT3-ITD–positive acute myeloid leukemia (AML).

While the study failed to reach its primary end point for relapse-free survival (RFS), patients treated with gilteritinib achieved a numerical but not statistically significant improvement in RFS (HR, 0.679; 95% CI, 0.459-1.005; 2-sided P = .0518).

According to Levis, gilteritinib appears to have a clear benefit for the 50% of patients with detectable minimal residual disease (MRD) pre- or post-transplant vs those without detectable MRD.

Transcription:

0:08 | MRD and the toxicity from the drug came in a lot of ways from azole use. The azole drove up the levels and use wasn't necessary and was often prophylactic. Just as much of the toxicity came from the patient and the physician not realizing they were on the drug, and that these toxicities could occur with a little bit of myelosuppression. The patient with MRD positivity, who was put on an azole for no particularly good reason, got myelosuppression, the drug was stopped and they relapsed.

0:45 | That's where an open-label setting isn't going to have that problem. If clinicians get another MRD-positive, I don't necessarily want to add an azole. The big message is, yes, you want to reserve the drug for MRD-positive patients if you can, with more uncertainty in the MRD-negative patients [where you should] watch the use of the azoles. By the way, the MRD assay is available right now to every clinician in the [United States] as an ordinary send out test and the technology is used widely around the world. So there's nothing magical about this.