MacroGenics Announces Positive Interim Phase 1 Results for MGC026 and Highlights Plans to Initiate Front-Line Combination Study in SCCHN
Key Highlights
- ➤MGC026 produced a 27% response rate in heavily pretreated SCCHN patients
- ➤MGC026 showed 29% confirmed responses across 10 solid-tumor types
- ➤MGC026’s median response duration reached 10.2 months
- ➤MacroGenics plans a front-line MGC026-pembrolizumab SCCHN study in early 2027
- ➤No treatment-related discontinuations occurred among SCCHN patients
Expert Statements
Eric Risser, President and Chief Executive Officer of MacroGenics
“The emerging profile of MGC026 reinforces our conviction that this molecule has the potential to play an important and differentiated role in the treatment of advanced solid tumors”
Eric Risser, President and Chief Executive Officer of MacroGenics
“We believe MGC026 is well positioned through the combination of a highly selective B7-H3-targeting antibody, a proprietary drug-linker technology and a potent TOP1 inhibitor payload”
Apostolia M. Tsimberidou, Lead principal study investigator, The University of Texas MD Anderson Cancer Center
“These preliminary Phase 1 data for MGC026 are encouraging and demonstrate a manageable safety profile and promising antitumor activity in heavily pretreated patients with advanced solid tumors”
Apostolia M. Tsimberidou, Lead principal study investigator, The University of Texas MD Anderson Cancer Center
“Importantly, of 22 heavily pretreated patients with SCCHN (expansion cohort), six (27.3%) had a partial response.”
Apostolia M. Tsimberidou, Lead principal study investigator, The University of Texas MD Anderson Cancer Center
“There was no drug-related treatment discontinuation, and no pneumonitis, ocular toxicities, or unexpected toxicities were noted.”
Apostolia M. Tsimberidou, Lead principal study investigator, The University of Texas MD Anderson Cancer Center
“Together, these findings support the continued clinical development of MGC026 in SCCHN and across multiple tumor types, including evaluation in combination regimens and earlier lines of therapy.”
Barbara Burtness, Anthony N. Brady Professor of Medicine and Chief of Head and Neck Cancers, Yale Cancer Center
“As new therapies emerge in head and neck cancer, differentiation will increasingly depend not only on antitumor activity, but also on durability, tolerability and the ability to be incorporated into combination regimens.”
Barbara Burtness, Anthony N. Brady Professor of Medicine and Chief of Head and Neck Cancers, Yale Cancer Center
“I believe the developing clinical profile of MGC026 positions this agent favorably among emerging therapies.”
Barbara Burtness, Anthony N. Brady Professor of Medicine and Chief of Head and Neck Cancers, Yale Cancer Center
“The planned pembrolizumab combination study represents an important next step in determining the potential role of MGC026 in earlier treatment settings.”
* Durable responses observed across multiple tumor types during dose escalation * MGC026 demonstrated 27% best overall response rate (6/22 patients; 4 confirmed and 2 unconfirmed PRs) in heavily pretreated SCCHN patients * MGC026 demonstrated manageable safety and tolerability profile with no treatment-related discontinuations in SCCHN patients * Plan to initiate front-line SCCHN cohort evaluating MGC026 in combination with pembrolizumab ROCKVILLE, MD, Oct. 23, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced positive interim data from its Phase 1 study evaluating MGC026, a B7-H3-directed antibody-drug conjugate (ADC), in patients with advanced solid tumors. These Phase 1 data were presented today at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain. These results demonstrated durable activity across a broad range of solid tumors, which the Company believes supports expanded development of MGC026 in front-line metastatic squamous cell carcinoma of the head and neck (SCCHN) in combination with pembrolizumab.
Get started
Create a free account to read the full story.