MGNX - MacroGenics announces positive results from late-stage MARGENZA study

MacroGenics (MGNX) announces positive data from its pivotal Phase 3 clinical trial SOPHIA testing its treatment MARGENZA (margetuximab-cmkb) in certain patients with breast cancer, in the Journal of the American Medical Association ((JAMA)) Oncology.The trial included 536 adult patients with metastatic HER2-positive breast cancer previously treated with two or more anti-HER2 regimens and from one to three lines of therapy for metastatic disease.In the study, MARGENZA showed a statistically significant 24% reduction in the risk of disease progression or death compared to Herceptin, each in combination with chemotherapy (Hazard Ratio [HR] = 0.76; 95% CI, 0.59-0.98; p=0.03; median PFS 5.8 vs. 4.9 months).Among 524 response-evaluable patients, the objective response rates for MARGENZA plus chemotherapy and trastuzumab plus chemotherapy were 22% and 16%, respectively (P=0.06) and the clinical benefit rates were 37% for MARGENZA and 25% for trastuzumab, (P=0.003).MacroGenics expects that MARGENZA will be available to patients in the U.S. in March 2021.The FDA had approved Margenza, in combination with chemotherapy, for

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MacroGenics announces positive results from late-stage MARGENZA study