Phase III HOVON 156 AML trial: Gilteritinib vs midostaurin in ND FLT3-mutated AML

Results from the phase III, multicenter, open-label HOVON 156 AML (NCT04027309) trial, also referred to as AMLSG28-18 or PASHA, evaluating gilteritinib (n = 384) vs midostaurin (n = 384) in adult patients with newly diagnosed (ND) acute myeloid leukemia (AML) were presented by Marc Raaijmakers at the European Hematology Association (EHA) 2026 Congress, Jun 11–14, 2026, Stockholm, SE. The primary endpoint was overall survival (OS), and key secondary endpoints included event-free survival (EFS), complete remission (CR) rate after induction, and modified EFS.

Key data: At an overall median follow-up of 43.2 months, the median OS was not reached (NR) in either group (hazard ratio [HR], 1.02; 95% confidence interval [CI], 0.81–1.28; p = 0.864). The CR rate after induction was 78.9% with gilteritinib vs 83.3% with midostaurin (p = 0.128), with CR with incomplete hematologic recovery (CRi) rates of 2.9% vs 3.6%. The median EFS was 51.1 months with gilteritinib vs 19.9 months with midostaurin (HR, 0.83; p = 0.052). Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 96.9% vs 96.6% of patients and serious adverse events (SAEs) occurred in 68.2% vs 59.4% of patients with gilteritinib vs midostaurin; the most common SAE in both arms was infections and infestations (43.2% vs 35.6%).

Key learning: The primary endpoint was not met, and gilteritinib and midostaurin demonstrated comparable OS in patients with ND FLT3m AML. Gilteritinib was generally well tolerated, with numerically greater rates of infectious SAEs than midostaurin.