MacroGenics, Inc. (NASDAQ: MGNX), shares zipped 13.27% in the post-market to reached $28. A biopharmaceutical corporation devoted to the production and promotion of novel cancer medication monoclonal antibody-based therapeutics has confirmed that the U.S. MARGENZA, in combination with chemotherapy, has been regulated by the FDA for the treatment of adult patients with metastatic HER2-positive breast cancer who have undergone two or more previous anti-HER2 regimens, plus at least one for metastatic disease.
MARGENZA is being further developed by MacroGenics, with funding from Zai Lab in Greater China, for the treatment of advanced gastric cancer. The acceptance in the U.S. for breast cancer was focused on the safety and effectiveness findings of the Phase 3 SOPHIA pivotal trial.
MARGENZA’s approval was based on the results of SOPHIA, a randomized Phase 3 clinical trial. This study included 536 patients and found a statistically significant 24% reduction in the risk of progression or death with MARGENZA plus chemotherapy compared with trastuzumab plus chemotherapy (P=0.033; median PFS 5.8 vs 4.9 months). The objective response rate for MARGENZA plus chemotherapy was 22% and for trastuzumab plus chemotherapy was 16%. The final Overall Survival (OS) analysis is expected in the second half of 2021.