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MacroGenics Announces Presentation of Flotetuzumab Translational Data at the 2020 AACR Annual Meeting
Rockville, MD, April 27, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and
About this update from Macrogenics, Inc.
[{"type":"text","content":"Rockville, MD, April 27, 2020 (GLOBE NEWSWIRE) -- \n MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced data related to flotetuzumab, an investigational, bispecific CD123 x CD3 DART® molecule being evaluated in patients with refractory acute myeloid leukemia (AML). The data will be presented during a plenary session at the American Association for Cancer Research (AACR) Virtual Annual Meeting I, taking place April 27-28, 2020. “Patients with TP53 mutated AML respond poorly to induction therapy and have a dismal prognosis. The current study suggests that TP53 mutational status correlated with an immune-infiltrated tumor microenvironment that was associated with response to flotetuzumab in our ongoing Phase 1/2 study in refractory disease,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “This analysis further elucidates potential immune drivers of response to flotetuzumab and supports its potential for treating patients with particularly challenging disease and who have limited treatment options.” The current study was conducted by Professor Sergio Rutella, M.D., Ph.D., FRCPath, at the John van Geest Cancer Research Centre at Nottingham Trent University in the UK, in collaboration with MacroGenics and NanoString Technologies, Inc. The data suggests that TP53 mutations in AML associate with an immune-infiltrated tumor microenvironment (TME) characterized by high expression of IFN-γ signaling molecules and immune checkpoints. This inflammation signature was previously found to be associated with response to flotetuzumab immunotherapy in a Phase 1/2 study in patients with AML who were refractory to induction treatment (primary induction failure). In this new study, among patients with TP53 mutated AML who were treated with flotetuzumab, 45.5% (5/11) showed evidence of anti-leukemic activity, including two patients with complete remission (CR), one patient with a CR with partial hematologic recovery (CRh), and one patient with morphologic leukemia-free state (MLFS) per International Working Group (IWG) criteria. Furthermore, median overall survival (OS) of flotetuzumab-treated patients with TP53 abnormalities was 4 months (range 1.25-21.25), compared to an est...