Rockville, MD, April 27, 2020 (GLOBE NEWSWIRE) --
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 estimated median OS of 1 month (Stichting Hemato-Oncologie voor Volwassenen Nederland, HOVON, Rotterdam, NL).
AACR Virtual Presentation
Title: TP53 abnormalities correlate with immune infiltration and are associated with response to flotetuzumab, an investigational immunotherapy, in acute myeloid leukemiaSession: VCTPL03 - Immunotherapy Clinical Trials 1Date: April 27, 2020Time: 1:25 pm - 1:35 pm ETLocation: AACR Virtual Annual Meeting I at www.aacr.org
After the presentation, Dr. Rutella’s slides will be available on the Events & Presentations page on MacroGenics’ website at http://ir.macrogenics.com/events.cfm.
About Acute Myeloid Leukemia
AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure) or experience disease recurrence after a short remission duration (