MacroGenics Pauses Enrollment in LINNET Trial Due to Safety Concerns

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MacroGenics, Inc., a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase 2 LINNET study of lorigerlimab, an investigational bispecific DART® molecule that targets PD-1 and CTLA-4, in patients with gynecologic cancers. Under the partial clinical hold, no new patients will be enrolled in the LINNET study until the partial hold is lifted by the FDA, though current study participants may continue to receive the study drug.

Why it matters

The partial clinical hold was initiated following recent safety events observed in the LINNET trial, including Grade 4 thrombocytopenia, Grade 4 myocarditis, and Grade 4 neutropenia with concurrent septic shock leading to a Grade 5 event. This pause in enrollment highlights the importance of closely monitoring patient safety in clinical trials, especially for investigational cancer therapies that may have complex mechanisms of action and potential side effects.

The details

To date, 41 study participants have been dosed at 6 mg/kg every 3 weeks across the platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancer (CCGC) cohorts. The LINNET study was evaluating lorigerlimab as monotherapy in a Simon two-stage trial in eligible patients with PROC who have received up to three prior lines of therapy, and in up to 20 patients with CCGC who have received at least one prior line of therapy. The primary endpoint is objective response rate (ORR), with multiple secondary endpoints.

• On February 23, 2026, MacroGenics announced the FDA's partial clinical hold on the LINNET trial.

What they’re saying

What’s next

MacroGenics plans to work closely with the FDA to resolve the partial clinical hold on the LINNET trial and resume enrollment of new study participants as soon as possible.