Dr. Altman on Gilteritinib in Patients With Relapsed/Refractory AML

Jessica K. Altman, MD, associate professor of medicine (hematology and oncology), Feinberg School of Medicine, Northwestern Medicine, discusses an early-phase study of gilteritinib in FLT3-mutation—positive patients with acute myeloid leukemia (AML).

This phase I/II study, which was recently published in Lancet Oncology, investigated gilteritinib in these relapsed/refractory patients with AML, Altman explains. Patients were not required to have FLT3 mutations, but researchers did enrich the patient cohort to have a larger number of patients with FLT3 mutations. The dose-escalation study had a primary endpoint of determining the maximum-tolerated dose, as well as assessing the safety, tolerability, associated toxicities, and anti-leukemic activity of the drug. The phase II component explored the efficacy of the agent.

Results showed that the maximum-tolerated dose was 300 mg once daily and common side effects seen were fatigue, diarrhea, elevation of liver function test, she adds.