MacroGenics reports Phase I data of flotetuzumab for AML
MacroGenics Inc. (NASDAQ:MGNX) reported preliminary data from 8 evaluable patients with acute myelogenous leukemia (AML) in a dose-expansion cohort of a Phase I trial showing that 500 ng/kg/day IV flotetuzumab (CD3xCD123 DART molecule, MGD006, S80880) led to a complete remission (CR) or CR with incomplete blood count recovery (CRi) in two patients and a morphologic leukemia-free state (MLFS) in one patient, plus three cases of stable disease. The most common adverse events reported were infusion-related reactions and cytokine release syndrome (CRS). Data were presented at the American Society of Hematology meeting in Atlanta in December.
The open-label, international trial is evaluating safety, maximum tolerated dose (MTD), pharmacokinetics and anti-leukemic activity in patients with AML or intermediate-2/high-risk myelodysplastic syndrome (MDS)...