MacroGenics (NASDAQ:MGNX) dosed the first patient in its Phase 2/3 MAHOGANY clinical trial of margetuximab for the treatment of HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
The trial will evaluate margetuximab, a HER2-targeting monoclonal antibody, in combination with a checkpoint inhibitor (CI), with or without chemotherapy, in two patient groups.
The first group consists of patients with HER2- and PD-L1-positive tumors who will receive margetuximab plus MGA012, an investigational anti PD-1 monoclonal antibody. The primary outcome measure is objective response rate.
The second group, consisting of patients with HER2-positive tumors, will receive either margetuximab plus a CI in combination with chemotherapy, or standard of care therapy of trastuzumab and chemotherapy. The primary outcome measure for efficacy is overall survival.
“The MAHOGANY study for patients with GC or GEJ is designed to support registration of margetuximab and is a part of our strategy to advance margetuximab in HER2-positive cancers,” president and CEO Dr. Scott Koenig said in a statement.
“The combination of margetuximab and a CI could potentially provide a chemotherapy-free option as a first-line treatment for patients whose tumors are positive for both HER2 and PD-L1 or be used with chemotherapy in a broader HER2-positive population to improve the clinical activity of existing standard of care,” he added.
