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MacroGenics Announces Initiation of Phase 2/3 MAHOGANY Study of Margetuximab in Gastric or Gastroesophageal Junction Cancer
Rockville, MD, Oct. 25, 2019 (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, Oct. 25, 2019 (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 that the first patient has been dosed in the Phase 2/3 MAHOGANY clinical trial of margetuximab, an investigational, Fc-optimized monoclonal antibody targeting HER2, in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. “The MAHOGANY study for patients with gastric or gastroesophageal junction cancer is designed to support registration of margetuximab and is a part of our strategy to advance margetuximab in HER2-positive cancers,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “The combination of margetuximab and a checkpoint inhibitor could potentially provide a chemotherapy-free option as a first-line treatment for patients whose tumors are positive for both HER2 and PD-L1 or be used with chemotherapy in a broader HER2-positive population to improve the clinical activity of existing standard of care.” The MAHOGANY Study Design MAHOGANY (NCT04082364) is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GEJ/GC. Module A is designed as a single arm study to test margetuximab plus MGA012 (also known as INCMGA00012), an investigational anti PD-1 monoclonal antibody, in patients with HER2-positive and PD-L1-positive tumors. The primary outcome measure for efficacy is objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST). Module B is designed as a randomized trial to test margetuximab plus a checkpoint inhibitor in combination with chemotherapy compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2-positive tumors irrespective of PD-L1 expression. Patients randomized to one of two experimental arms containing a checkpoint inhibitor will receive either MGA012 or MGD013, an investigational DART® molecule targeting PD-1 and LAG-3. The primary outcome measur...