MGAH 22 filed with FDA for HER2-positive breast cancer.- MacroGenics

MacroGenics announced that the Company has submitted to the FDA a Biologics License Application (BLA) for MGAH 22 (margetuximab), an investigational, Fc-engineered, monoclonal antibody that targets HER2 breast cancer. The margetuximab BLA is for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results of the pivotal phase III SOPHIA study, which were first presented at the 2019 American Society of Clinical Oncology annual meeting, with updated data recently presented at the 2019 San Antonio Breast Cancer Symposium.

The SOPHIA study (NCT02492711) is a randomized, open-label Phase III clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer, who have previously been treated with anti-HER2-targeted therapies. All study patients had previously received trastuzumab and pertuzumab, and approximately 90% had previously received ado-trastuzumab emtansine, or T-DM1.

Comment: Margetuximab is an investigational monoclonal antibody that targets the HER2 oncoprotein. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, the Fc region of margetuximab has been engineered to enhance the engagement of the immune system. Margetuximab is also being evaluated in combination with anti-PD-1 therapy for the potential treatment of patients with HER2-positive gastric or gastroesophageal junction cancer.