FDA Lifts Partial Clinical Hold on MacroGenics' Phase 2 LINNET Study of Lorigerlimab for Gynecologic Cancers
MacroGenics, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on its Phase 2 LINNET study of lorigerlimab. This regulatory decision enables the company to resume enrollment of new participants in the study, which investigates the bispecific DART® molecule targeting PD-1 and CTLA-4 in patients with gynecologic cancers. While previously enrolled participants continued to receive the study drug during the hold, new participants will now be enrolled under a revised protocol incorporating additional risk-mitigation measures. This development is a significant positive step for MacroGenics, allowing the advancement of a key pipeline asset and keeping the company on track for a mid-2026 program update.
Key Highlights
- The U.S. Food and Drug Administration (FDA) removed the partial clinical hold on MacroGenics' Phase 2 LINNET study.
- The LINNET study evaluates lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4.
- The study is focused on patients with gynecologic cancers.
- The removal of the hold allows MacroGenics to resume enrollment of new participants in the study.
- New participants will be enrolled under a revised protocol that includes additional risk-mitigation measures.
- MacroGenics remains on track to provide a mid-2026 program update for the lorigerlimab program.