FDA Pauses Enrollment in MacroGenics' LINNET Trial Over Safety Concerns
Event summary
- The FDA placed a partial clinical hold on MacroGenics' Phase 2 LINNET trial of lorigerlimab, halting new patient enrollment due to safety events.
- Safety issues included Grade 4 thrombocytopenia (2 patients), Grade 4 myocarditis (1 patient), and a Grade 5 event from neutropenia and septic shock (1 patient).
- 41 patients have already been dosed in the trial, which targets gynecologic cancers with lorigerlimab, a bispecific DART® molecule.
- Current participants can continue treatment, but no new enrollments are allowed until the FDA lifts the hold.
The big picture
MacroGenics' LINNET trial pause highlights the risks of developing novel bispecific antibodies, where safety profiles remain a critical hurdle. The FDA's intervention underscores the agency’s cautious stance on advanced immunotherapies, particularly those targeting multiple immune checkpoints like PD-1 and CTLA-4. This development could influence investor sentiment around MacroGenics' pipeline and its ability to secure future partnerships or funding.
What we're watching
- Regulatory Resolution
- How quickly MacroGenics can address the FDA's concerns and resume enrollment in the LINNET trial.
- Safety Profile Impact
- Whether the observed safety events will affect lorigerlimab’s long-term viability as a therapeutic candidate.
- Clinical Development Pace
- The pace at which MacroGenics can advance other trials while managing this regulatory setback.
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