Patient Death Triggers FDA Partial Clinical Hold on MacroGenics' LINNET Trial for Gynecologic Cancers

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The FDA placed a partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab, a bispecific antibody targeting PD-1 and CTLA-4, in patients with platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancer (CCGC), halting new patient enrollment while allowing current participants to continue treatment.124

The hold followed MacroGenics' notification of serious safety events in four patients:
Grade 4 thrombocytopenia (2 cases), Grade 4 myocarditis (1 case), and Grade 4 neutropenia with septic shock leading to a fatal Grade 5 event (1 case).134

To date, 41 patients have been dosed at 6 mg/kg every 3 weeks across the PROC and CCGC cohorts, out of a planned enrollment of around 60.124

MacroGenics CEO Eric Risser emphasized patient safety as the top priority and committed to working with the FDA to lift the hold and resume enrollment soon.145

The announcement was made on February 23, 2026, leading to an initial 8% drop in MacroGenics' stock price to $1.60 before partial recovery.4

Sources:

1. https://www.biospace.com/press-releases/macrogenics-announces-pausing-of-enrollment-of-new-study-participants-in-linnet-trial

2. https://www.nasdaq.com/articles/macrogenics-pauses-enrollment-participants-linnet-trial-fdas-partial-clinical-hold

3. https://www.ainvest.com/news/macrogenics-linnet-hold-impact-catalyst-path-2602/

4. https://www.biospace.com/drug-development/patient-death-forces-partial-freeze-on-macrogenics-gynecologic-cancer-study

5. https://www.cancernetwork.com/view/fda-issues-partial-clinical-hold-on-lorigerlimab-trial-in-gynecologic-cancers