In a pivotal clinical trial, VANFLYTA, when added to standard chemotherapy and used as maintenance, demonstrated a significant improvement in overall survival for adult patients with newly diagnosed FLT3-ITD positive AML.

Efficacy of VANFLYTA in Newly Diagnosed FLT3-ITD Positive AML

The efficacy of VANFLYTA was established in the QuANTUM-First study, a randomized, double-blind, placebo-controlled trial involving 539 patients with newly diagnosed FLT3-ITD positive AML. Patients received VANFLYTA or placebo in combination with induction (7+3 regimen) and consolidation chemotherapy, followed by maintenance monotherapy. The primary endpoint was overall survival (OS). The study demonstrated a statistically significant improvement in OS for patients in the VANFLYTA arm compared to the placebo arm. The median age of patients was 56 years. Twenty-nine percent of patients underwent HSCT in first complete remission.