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Thursday, December 19, 2019

MacroGenics files U.S. application for margetuximab for HER2+ breast cancer

MacroGenics (MGNX +3.3%) has filed its U.S. marketing application seeking approval of margetuximab for the treatment of metastatic HER2-positive breast cancer (combined with chemo).
Interim late-stage data presented last week in San Antonio showed that median overall survival in patients receiving the combo was only marginally better (21.6 months vs. 19.8 months) that Roche’s Herceptin (trastuzumab) + chemo. The OS data are expected to mature in H2 2020.
Margetuximab is an HER2-targeting monoclonal antibody that the company is also developing for gastroesophageal cancer (in combination with a PD-1 inhibitor).

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