This open-label, multi-dose, single-arm, multi-center Phase 1, dose-escalation study was conducted in 60 patients with HER2-positive (2+ or 3+ by immunohistochemistry, or IHC) neoplasms, including 23 with breast cancer, and was aimed at defining the toxicity profile, maximum tolerated dose, pharmacokinetics, immunogenicity and potential anti-tumor activity of margetuximab (MGAH22).
Margetuximab was administered by IV infusion once per week for 4 weeks in the following dose escalation cohorts: 0.1, 0.3, 1.0, 3.0, and 6.0 mg/kg; and once every 3 weeks in the following dose escalation cohorts: 10.0, 15.0, and 18.0 mg/kg. Study results showed that margetuximab was well-tolerated at all explored doses, including the highest dose tested. Infusion reactions were generally mild overall and were well controlled with pre-medication.
The most common adverse events (AEs) were Grade 1-2 constitutional symptoms and infusion-related reactions. No cardiac dysfunction was observed. Monotherapy anti-tumor activity was observed across several tumor types, including patients with gastric, colorectal and head and neck cancer as well as patients with breast cancer who had received extensive prior therapy and progressed on prior HER2-directed therapy. Tumor reductions were observed in 13 of 19 evaluable patients with breast cancer, including 4 of 19 patients with confirmed partial responses. In this population, a median progression-free survival (PFS) of approximately 5.5 months was observed.
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Margetuximab is an antibody that targets HER2-expressing tumors, including certain types of breast and gastroesophageal cancers. Human epidermal growth factor receptor 2, or HER2, is critical for the growth of many types of tumors. Using its Fc-optimization platform, the Company has engineered the Fc-region of margetuximab to increase margetuximab's ability to kill tumor cells through an Fc-dependent mechanism, including antibody dependent cell-mediated cytotoxicity, or ADCC. In addition to its anticipated Phase 3 SOPHIA study in metastatic breast cancer, the Company also plans to commence an exploratory Phase 1/2 study in the fourth quarter of 2015 combining margetuximab with another immuno-oncology therapeutic in patients with gastroesophageal cancer.
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uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risk factors described in the Company's filings with the
Jim Karrels, Senior Vice President, CFO MacroGenics, Inc.1-301-251-5172, firstname.lastname@example.org Karen Sharma, Vice President MacDougall Biomedical Communications1-781-235-3060, email@example.com
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