The FDA has approved margetuximab-cmkb (Margenza) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which for metastatic disease.The regulatory decision was based on findings from the phase 3 SOPHIA trial (NCT02492711), in which the Fc-engineered monoclonal antibody plus chemotherapy demonstrated a statistically significant reduction in the risk of disease progression or death of 24% vs trastuzumab (Herceptin) in combination with chemotherapy (HR, 0.76; 95% CI, 0.59-0.98; P =.033).

The median PFS with the margetuximab-cmkb regimen was 5.8 months vs 4.9 months with the trastuzumab regimen. Moreover, the objective response rate reported with the margetuximab-cmkb/chemotherapy combination was 22% vs 16% with trastuzumab plus chemotherapy. Data from the final overall survival (OS) analysis of the trial are anticipated to be released in the second half of 2021, according to MacroGenics, Inc.

“The approval of [margetuximab-cmkb] is an exciting milestone for MacroGenics and, more importantly, it brings a new treatment option to metastatic breast cancer patients. We are grateful for the patients who participated in this study, as well as their families, and everyone who played a role in helping MacroGenics reach this milestone,” Scott Koenig, MD, PhD, president and CEO of MacroGenics, stated in a press release.

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