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MacroGenics Announces Closure of CP-MGA271-06 Study Evaluating Enoblituzumab plus Checkpoint Inhibition in Head and Neck Cancer
ROCKVILLE, MD, July 08, 2022 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing
About this update from Macrogenics, Inc.
[{"type":"text","content":"ROCKVILLE, MD, July 08, 2022 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that effective as of July 7, 2022, the Company closed the Phase 2 study (CP-MGA271-06) evaluating the investigational regimen of enoblituzumab (Fc-optimized B7-H3-directed monoclonal antibody) in combination with either retifanlimab (anti-PD-1 monoclonal antibody) or tebotelimab (PD-1 × LAG-3 bispecific DART® molecule) in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The decision to discontinue the study was based on an internal review of safety data, which included the occurrence of seven fatalities potentially associated with hemorrhagic events in both arms of the study (of 62 total patients treated). Six of the seven fatal events observed in the CP-MGA271-06 study were assessed by investigators as secondary to disease progression and/or unrelated to the study treatment, and one event was assessed as possibly related. Fatal tumor-related hemorrhages and airway obstruction are known risks in patients with SCCHN. The incidence of fatal events observed in the study that were potentially hemorrhagic in origin was higher than what has been reported for this patient population in the medical literature (i.e., 1 - 3.6% as per Argiris, et al., J Clin Oncol. 2019 Dec 1, 37(34):3266) and in the context of a risk : benefit analysis, prompted the Company’s decision to close the study. Accordingly, the Company informed investigators and the U.S. Food and Drug Administration (FDA) of the study closure and instructed investigators that no additional patients in the study were to be enrolled or receive further treatments as of July 7, 2022. MacroGenics continues to investigate and monitor these events, and an analysis of the data is ongoing. There were no hemorrhagic events or coagulopathies observed in nonclinical toxicology studies of enoblituzumab, and the incidence of any fatal hemorrhage reported in earlier studies of enoblituzumab evaluated in over 340 patients across a broad range of tumor types was less than 1%. “Our top concern in conducting clinical trials is the safety of study participants,” said Scott Koenig, M.D., Ph.D., Pr...