MacroGenics announces final overall survival results from SOPHIA study of margetuximab-cmkb (margenza™) in patients with HER2-Positive metastatic breast cancer
In phase 3 study, overall survival analysis did not show a statistically significant advantage for margetuximab-cmkb over trastuzumab in combination with chemotherapy with median survival of 21.6 months vs 21.9 months, respectively, in ITT population (HR=0.95; 95% CI: 0.77-1.17).
Source:
Biospace Inc.
SPS commentary:
Margetuximab is an Fc-optimised chimeric second-generation anti-HER2 monoclonal antibody. It has been engineered to increase the affinity of the Fc domain for both CD16A alleles and decrease the affinity for the inhibitory receptor, FcγRIIB.
In 2020, margetuximab was approved by U.S. FDA in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Approval was based on progression-free survival results for margetuximab regimen from the SOPHIA study (n=536; 5.8 vs 4.9 months; HR 0.76; 95% CI, 0.59-0.98; P = 0.03). The final overall survival data now reported will be submitted to the FDA.