FDA partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab after severe safety events

MACROGENICS INC

Partial hold halts new enrollment; current participants may continue receiving lorigerlimab.
Safety events across 4 patients: Grade 4 thrombocytopenia (2), myocarditis (1), neutropenia with septic shock (1) leading to 1 death (Grade 5).
41 patients dosed at 6 mg/kg every 3 weeks in platinum-resistant ovarian and clear cell gynecologic cancer cohorts.
MacroGenics commits to working with FDA to resolve the hold and resume enrollment.

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