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MacroGenics Announces Registration Study of Flotetuzumab in Patients with Refractory Acute Myeloid Leukemia
Rockville, MD, May 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, May 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 plans for a clinical study intended to support registration in the U.S. of flotetuzumab, an investigational, bispecific CD123 x CD3 DART® molecule for patients with acute myeloid leukemia (AML) who are refractory to induction therapy. Informed by recent discussions with the U.S. Food and Drug Administration (FDA), the Company plans a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with primary induction failure (PIF) or early relapse (ER) AML. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956; to be updated). Complete remission (CR) and CR with partial hematological recovery (CRh) will be the primary endpoint of the pivotal study. Key secondary endpoints will include durability of response and other supportive clinical endpoints. “Patients with AML who are refractory to induction therapy or relapse early after an initial response have limited treatment options,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Clinical and translational data suggest that such refractory AML patients may be responsive to immunotherapy with flotetuzumab. We are very pleased to advance our first DART molecule into a pivotal study with an opportunity to address a significant unmet need.” Data from the Phase 1/2 clinical study of flotetuzumab in patients with PIF/ER AML were presented in December 2019 at the American Society of Hematology (ASH) Annual Meeting. A CR/CRh rate of 27% (8 of 30) was observed in the intent-to-treat population. The most common treatment-related adverse event was infusion-related reaction/cytokine release syndrome that occurred in all patients and was mostly of short duration and mild to moderate (grade 1 or 2) in severity. 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% o...