FDA approves immuno-optimized HER2 monoantitherapy for the treatment of metastasis HER2-positive breast cancer

Human skin growth factor 2 (HER2) is a growth-promoting protein found on the surface of some cancer cells, associated with invasive diseases and poor prognostoficity.
about 15-20% of breast cancer cases are HER2-positive.
monoclonal antibodies that target HER2 have greatly improved treatment outcomes, however, a large number of patients will still develop the disease and need innovative therapies.
Margenza (margetuximab-cmkb) is a monoclonal antibody optimized for Fc, targeting the HER2 protein.
similar to crater bead monoantigen, margetuximab-cmkb inhibits tumor cell proliferation, reduces the shedding of HER2 extracellular areas, and mediates antibody-dependent cytotoxicity (ADCC).
, margetuximab-cmkb enhances the immune system's involvement through MacroGenics' Fc optimization technology.
in-body tests, the Fc region of margetuximab-cmkb enhances the binding to the active Fc subject FCGR3A (CD16A) and reduces the binding to the inhibitory Fc subject FCGR2B (CD32B).
these changes lead to stronger in-body ADCcs and natural killing (NK) cells.
margenza is based on data from SOPHIA, a randomized Phase 3 clinical trial.
the study included 536 patients who had been treated with HER2 targeted therapy and the disease continued to progress.
studies showed that Margenza plus chemotherapy significantly reduced the risk of disease progression or death by 24% compared to the active control group (HR s 0.76; 95% CI, 0.59-0.98; P s 0.033; with a medium progression-free survival of 5.8 months vs 4.9 months).
the objective remission rate of Margenza's chemotherapy combination was 22 percent, compared with 16 percent in the control group.
Final Total Lifetime (OS) analysis is expected to take place in the second half of 2021.
: s1. MacroGenics Announces FDA Approval of MARGENZA™ For Patients with Pretreated Metastatic HER2-Positive Breast Cancer. Retrieved 2020-12-17, from Source: Supplied