When combined with chemotherapy, margetuximab has shown to improve progression-free survival (PFS) over trastuzumab in pretreated patients with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer. Safety of the two agents was comparable.
Pretreated HER2-positive metastatic breast cancer lacks a defined standard of care, although trastuzumab is commonly used. Margetuximab is an antibody designed to activate an immune response which has a similar HER2-binding and antiproliferative effects as trastuzumab. One difference is that its Fcγ region is engineered to increase affinity for both alleles of the activating Fc receptor CD16A and to decrease affinity for the inhibitory Fc receptor CD32B. The low affinity CD16A-158F allele (~85% of population) has been associated with diminished clinical response to trastuzumab.
The SOPHIA trial was a randomised, open-label phase 3 trial which enrolled 536 patients with HER2-positive metastatic b...
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