FDA Lifts Partial Hold on MacroGenics' LINNET Study of Lorigerlimab
Event summary
- FDA removed the partial clinical hold on MacroGenics’ Phase 2 LINNET study of lorigerlimab, a bispecific DART® molecule targeting PD-1 and CTLA-4.
- Enrollment in the study will resume under a revised protocol with additional risk-mitigation measures for hematologic and cardiac toxicities.
- The LINNET study evaluates lorigerlimab in up to 60 patients with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC).
- MacroGenics plans to provide a mid-2026 clinical update on the program.
The big picture
The FDA's decision to lift the partial clinical hold on the LINNET study is a critical milestone for MacroGenics, allowing the company to advance its bispecific antibody candidate, lorigerlimab. This development comes at a time when the biopharmaceutical industry is increasingly focused on innovative cancer therapies targeting immune checkpoints like PD-1 and CTLA-4. The success of this program could position MacroGenics as a key player in the gynecologic oncology space, provided it can demonstrate both efficacy and safety in upcoming clinical updates.
What we're watching
- Clinical Progress
- How the resumption of enrollment in the LINNET study will impact the timeline for lorigerlimab's development and potential regulatory approval.
- Safety Monitoring
- Whether the additional risk-mitigation measures will effectively address hematologic and cardiac toxicities observed in previous studies.
- Market Positioning
- The pace at which MacroGenics can differentiate lorigerlimab in a competitive landscape of gynecologic cancer treatments.
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