Patient Death Prompts MacroGenics To Close Mid-Stage Head & Cancer Study

Patient Death Prompts MacroGenics To Close Mid-Stage Head & Cancer Study
  • MacroGenics Inc MGNX closed the Phase 2 study (CP-MGA271-06) of enoblituzumab in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
  • The trial evaluated the regimen of enoblituzumab in combination with either retifanlimab or tebotelimab.
  • The decision to discontinue the study was based on an internal review of safety data, which included seven fatalities potentially associated with hemorrhagic events in both arms of the study (of 62 total patients treated). 
  • Investigators assessed six of the seven fatal events observed in the study as secondary to disease progression and/or unrelated to the study treatment.
  • One event was assessed as possibly related. Fatal tumor-related hemorrhages and airway obstruction are known risks in patients with SCCHN. 
  • Accordingly, the company informed investigators and the FDA of the study closure and instructed investigators that no additional patients in the study were to be enrolled or receive further treatments.
  • MacroGenics continues to investigate and monitor these events, and an analysis of the data is ongoing.
  • Price Action: MGNX shares closed 2.86% lower at $3.40 during after-hours trading on Friday.

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