A study presented at the 2022 Society of Hematologic Oncology (SOHO) Annual Meeting showed daily doses of gilteritinib plus induction and consolidation chemotherapy followed by gilteritinib maintenance led to acceptable safety outcomes and efficacy in patients with FLT3-mutated acute myeloid leukemia (AML).
The four-part, open-label, phase I study assessed gilteritinib dose schedules in patients with newly diagnosed AML. Patients received a daily dose of gilteritinib plus 7+3 induction with idarubicin or daunorubicin, plus three or fewer cycles of high-dose cytarabine and gilteritinib consolidation, and two years of single-agent gilteritinib maintenance post-consolidation or transplant.
In this portion of the study, 80 patients received doses of gilteritinib plus induction and consolidation chemotherapy, 78 of whom were available for the safety analysis. After a median follow-up of 37.7 months, 24.4% of patients discontinued treatment due to adverse events. About a third of patients (n=27; 33.8%) went on to receive hematopoietic stem cell transplant.
Dose-limiting toxicities occurred in 19.2% of patients (n=15), and the maximum tolerated gilteritinib dose was 120 mg/day.
Among the overall (n=79) and FLT3-mutated (n=44) populations, composite complete remission (CR) occurred in 79.7% and 90.9% of patients, respectively. In these cohorts, the 60-day mortality rates were 1.3% and 0%, respectively, and median disease-free survival was 15.1 months for both cohorts. Estimated three-year overall survival rates were 56.0% and 60.1%, respectively.
“Gilteritinib plus induction and consolidation chemotherapy was well tolerated and resulted in CR, FLT3-ITD clearance, and long-term survival in patients with newly diagnosed FLT3-mutated AML, supporting ongoing randomized trials testing this approach against current standards,” the researchers concluded.
Pratz KW, Cherry M, Podoltsev NA, et al. A phase 1 study of gilteritinib in combination with induction and consolidation chemotherapy in patients with newly diagnosed acute myeloid leukemia: final study results. Abstract #AML-256. Presented at the 2022 Society of Hematologic Oncology (SOHO) Annual Meeting, September 28-October 1, 2022.