other material
confidence high
sentiment negative
materiality 0.70
MacroGenics closes Phase 2 enoblituzumab study after 7 hemorrhagic fatalities in head and neck cancer
MACROGENICS INC
- Phase 2 study CP-MGA271-06 closed due to 7 fatal hemorrhagic events among 62 SCCHN patients.
- 6 of 7 deaths assessed as unrelated to study treatment; 1 possibly related; incidence exceeded literature rate of 1–3.6%.
- Prior enoblituzumab studies in >340 patients had <1% fatal hemorrhage; nonclinical tox showed no coagulopathy.
- Company informed FDA and investigators; no new patients enrolled or treated as of July 7, 2022.
- Closure does not affect ongoing MGC018 ADC program; internal review and data analysis continue.