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Margetuximab is an investigational, Fc engineered HER2-directed monoclonal antibody. Margetuximab-cmkb binds to the extracellular domain of the human epidermal growth receptor protein (HER2). Upon binding to HER2-expressing tumor cells, margetuximab-cmkb inhibits tumor cell proliferation, reduces shedding of the HER2 extracellular domain and mediates antibody-dependent cellular cytotoxicity (ADCC).
In vitro, the modified Fc region of margetuximab increased binding to activating Fc receptor FCGR3A (CD16A) and decreased binding to inhibitory Fc receptor FCGR2B (CD32B). These changes led to greater in vitro antibody-dependent cellular cytoxicity (ADCC) and NK cell activation. The clinical significance of in vitro data is unknown.
For approved indications in the U.S., click here.
Patients are currently being enrolled in the Phase 2/3 MAHOGANY study (NCT04082364) of margetuximab plus a checkpoint inhibitor (retifanlimab or tebotelimab) with or without chemotherapy in first-line patients with advanced HER2-positive gastric or gastroesophageal junction cancer.
MacroGenics is collaborating on the development and commercialization of margetuximab with Zai Lab in Greater China and GC Pharma in South Korea. MacroGenics retains full development and commercialization rights in all other territories and has partnered with EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry, to commercialize margetuximab in the United States.
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.