- Anti-B7-H3 antibody is well-tolerated
- Single-agent, anti-tumor activity observed across several tumor types
- Initial evidence of T-cell immunomodulatory role
This study is being conducted to evaluate the safety of enoblituzumab in patients with advanced cancer that expresses B7-H3 in the tumor and/or tumor-associated vasculature. Additional study objectives are to define the toxicity profile, maximum tolerated dose, pharmacokinetics, immunogenicity and potential anti-tumor activity of
enoblituzumab in patients with refractory cancer that expresses B7-H3.
Enoblituzumab has been well tolerated at all dose levels tested in the Phase 1 study (up to 15 mg/kg), with Grade 3/Grade 4 drug-related adverse events (AEs) in only 4% of patients, no severe immune-related adverse events, and no drug-related treatment discontinuations. The most common AEs have been infusion-related reactions and fatigue. Mild-moderate infusion reactions have been readily managed with conventional supportive care, including administration of corticosteroids and a decreased infusion rate.
In this ongoing Phase 1 dose-escalation study of enoblituzumab, monotherapy anti-tumor activity was observed across several tumor types, including patients with prostate and bladder cancer as well as melanoma. Overall, this patient population had been heavily pre-treated (median number of prior therapies = 3), and in the patients with melanoma, all had been treated previously with one or more checkpoint inhibitors (anti-CTLA-4, anti-PD-1 and/or anti-PD-L1 antibodies).
In addition to the presentation of initial safety and activity data,
"We are encouraged by the initial single-agent activity of enoblituzumab, including tumor regression in heavily pre-treated patients across several tumor types," said
Dr. Powderly's slide presentation at SITC is available for download from the Events & Presentations page on
Background on Enoblituzumab (MGA271)
Enoblituzumab is a humanized, Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of molecules that are involved in immune regulation. B7-H3 is over-expressed by a wide variety of solid tumor cells as well as cancer stem cells and tumor-associated vasculature. Enoblituzumab is currently undergoing Phase 1 testing both as monotherapy and in combination with checkpoint inhibitors across patients with a wide range of solid tumors.
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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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