FDA Puts Partial Hold on MacroGenics’ LINNET Trial After Patient Death
MacroGenics received a partial clinical hold on its Phase 2 LINNET study after four patients experienced severe adverse events, including one death, across 41 dosed participants at 6 mg/kg every three weeks. The company paused enrollment while working with FDA to address Grade 4 thrombocytopenia, myocarditis, neutropenia and septic shock.
1. FDA Partial Hold on LINNET Study
FDA placed a partial clinical hold on MacroGenics’ Phase 2 LINNET trial evaluating lorigerlimab in platinum-resistant ovarian and clear cell gynecologic cancers following safety concerns raised during the study.
2. Safety Events Prompt Enrollment Pause
The hold was triggered by four severe adverse events among 41 patients dosed at 6 mg/kg every three weeks, including two cases of Grade 4 thrombocytopenia, one Grade 4 myocarditis, and one Grade 4 neutropenia with concurrent septic shock resulting in a patient death.
3. Management Response and Next Steps
MacroGenics has paused new participant enrollment and is working with FDA to resolve the hold, aiming to address safety issues and resume dosing once the hold is lifted.