Clinical Trials

Date: 2015-10-22

Type of information: Initiation of development program

phase: 1b-2

Announcement: initiation of development program

Company: Macrogenics (USA - MD) Merck&Co (USA - NJ)

Product: margetuximab and pembrolizumab

Action mechanism:

monoclonal antibody/immune checkpoint inhibitor. Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2. Using its Fc-optimization platform, MacroGenics has designed the Fc region of margetuximab to enhance the killing of tumor cells through an Fc-dependent mechanism, including antibody dependent cell-mediated cytotoxicity, or ADCC.
Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system..

Disease: advanced HER2-positive gastric cancer

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

This main purpose of this clinical study is to learn about the safety and activity of margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and gastroesophageal junction cancer. (NCT02689284)

Latest news:

• On October 22, 2015, MacroGenics and Merck&Co announced a collaboration to evaluate the combination of MacroGenics' anti-HER2 product candidate, margetuximab, with Merck's anti-PD-1 therapy, Keytruda® (pembrolizumab), in a Phase 1b/2 clinical trial in patients with advanced gastric cancer. The Phase 1b/2 multicenter, open-label clinical trial will be conducted in two parts. The Phase 1b portion is designed to determine the safety and tolerability of margetuximab in combination with Keytruda® in patients with advanced gastric cancer, while the Phase 2 portion will evaluate the anti-tumor activity of margetuximab in combination with Keytruda® in patients with advanced HER2-positive gastric cancer. Trial startup activities are underway and MacroGenics expects to begin enrolling patients by the first quarter of 2016. The agreement includes a provision where the parties may extend the collaboration to include a potential Phase 3 clinical trial. The agreement is between MacroGenics and Merck&Co, through a subsidiary. Additional details were not disclosed.