MacroGenics Inc. (NASDAQ:MGNX) after leaping on 6th February the stock has been on a downward trajectory in the last few days and in the last trading session it lost 10.66% closing at $22.87 per share.
The decline in stock comes at the back of the company releasing positive results for its third phase SOPHIA clinical trial of Margetuximab in patients with HER2 metastatic breast cancer.
The SOPHIA Study
Margetuximab is an immune enhancing monoclonal antibody based on MacroGenics’ proprietary Fc Optimization platform. Results of the SOPHIA study achieved the primary endpoint of extending progression-free survival in those patients who received treatment of the combination of chemotherapy and margetuximab relative those who received a combination of trastuzumab and chemotherapy.
Results indicate that those patients treated with margetuximab had a 24% PFS risk reduction relative to the trastuzumab arm. 85% of the patients were CD16A 158F allele carriers that have association with the reduced clinical response to HERCEPTIN as well as other antibodies.
The company is currently preparing the results of the SOPHIA trial for publications and they will present them in a major scientific conference later in the year. The process of determination of outcomes on the primary endpoint on OS is under progress as per the recommendations of the Data Safety Monitoring Committee. MacroGenics is anticipating submission of Biologics License Application to the FDA by June this year.
Positive data milestone in treatment of HER+ breast cancer
Hope Rugo, the Director Breast Oncology and Clinical Trials, indicates that currently there is no agent with approval to treat HER+ metastatic breast cancer from previous trials of pertuzumab, tratsuzumab as well as ado-trastuzumab. Therefore the positive results from the SOPHIA trial is a big milestone and if margetuximab gets approval it will be great milestone in treatment of HER+ breast cancer patients.
MacroGenics CEO and President, Scott Koenig, indicated that the company was pleased to get positive results in the SOPHIA trial and they were grateful to caregivers and patients as well as investigators and all the personnel involved in the study. He added that the MacroGenics Fc-Optimization technology has shown superior outcome in the study against HERCEPTIN.