Efficacy of Margetuximab vs Trastuzumab in Patients With …
The phase 3 SOPHIA trial compared margetuximab, a novel chimeric Fc-engineered anti-ERBB2 antibody, to trastuzumab, each with chemotherapy, in patients with pretreated ERBB2-positive ABC. This randomized clinical trial was positive for its PFS primary end point.
Profile of Margetuximab: Evidence to Date in the Targeted …
Apr 28, 2022 · Margetuximab is a chimeric and Fc-optimized mAB directed to HER2 currently approved in combination with chemotherapy for the treatment of advanced HER2+ breast cancer. This drug represents another option for the treatment of patients with metastatic disease.
First-in-human phase 1 study of margetuximab (MGAH22), an Fc …
Jan 24, 2017 · This is the first-in-human clinical trial of margetuximab, a next-generation Fc-modified anti-HER2 mAb. Margetuximab binds to HER2 with high affinity and produces direct growth suppression of HER2-expressing tumor cell lines.
Margetuximab Versus Trastuzumab in Patients With Previously …
Nov 4, 2022 · Margetuximab-cmkb is an Fc-engineered anti–human epidermal growth factor receptor 2 (anti-HER2) immunoglobulin G monoclonal antibody that targets the same epitope as trastuzumab, with similar antiproliferative effects. 1,2 Compared with trastuzumab, margetuximab was designed to increase binding affinity (in vitro) for activating Fcγ receptor ...
A Review of Margetuximab-Based Therapies in Patients with …
Margetuximab is an Fc-optimized mAb that binds to ECD IV of the HER2 receptor, thus preventing the formation of HER2–HER2 homodimers and ligand-independent HER2–HER3, HER2–HER1, and HER2–HER4 complexes/heterodimers.
Efficacy of Margetuximab vs Trastuzumab in Patients With …
Apr 1, 2021 · The chimeric antibody margetuximab shares ERBB2 specificity with trastuzumab but incorporates an engineered Fc region to increase immune activation. Objective: To compare the clinical efficacy of margetuximab vs trastuzumab, each with chemotherapy, in patients with pretreated ERBB2-positive ABC.
First-in-human phase 1 study of margetuximab (MGAH22), an Fc …
Apr 1, 2017 · Background: Margetuximab is an anti-HER2 antibody that binds with elevated affinity to both the lower and higher affinity forms of CD16A, an Fc-receptor important for antibody dependent cell-mediated cytotoxicity (ADCC) against tumor cells.
FDA Approval Summary: Margetuximab plus chemotherapy for …
Margetuximab (MGAH22) is a human/mouse chimeric Fc-engineered IgG1 kappa monoclonal antibody generated in Chinese hamster ovary cells and purified by standard bioprocessing procedures. The variable domains of margetuximab are derived from the same murine precursor as trastuzumab (4D5) to bind to extracellular domain IV of HER2 ( 15 ).
Margetuximab: An active alternative for later‐line therapy in …
Jul 4, 2023 · As enhanced trastuzumab activity was observed in CD32B‐deficient mice, the Fc region of margetuximab was also modified for decreased CD32B binding. 4 Overall, the optimized Fc domain enhances margetuximab‐induced ADCC in HER2‐positive tumors even with low HER2 expression, thereby improving the curative effect regardless of the FcγR variant.
Introduction: Margetuximab (M) is an investigational Fc-engineered anti-HER2 monoclonal antibody (mAb) with potential for greater immune-mediated anti-tumor activity than trastuzumab (T). M and T bind the same subdomain IV epitope, but M binds with higher affinity to activating Fc receptor, CD16A (FcgRIIIA), and lower