MacroGenics, the Rockville, Maryland-based biopharmaceutical company, announced on April 8, 2026 that the US FDA has removed a partial clinical hold on the Phase II LINNET study of lorigerlimab in gynecologic cancers, with the company stating it will resume enrollment of new participants under a revised protocol that incorporates additional risk-mitigation measures for hematologic and cardiac toxicities.
The partial hold had permitted previously enrolled participants to continue receiving study drug throughout its duration. The company cited productive engagement with the FDA's Office of Oncologic Diseases and said it remains on track to provide a clinical program update in mid-2026.
The LINNET study (NCT06730347) is a Phase II, single-agent trial evaluating lorigerlimab in up to approximately 60 participants with either platinum-resistant ovarian cancer or clear cell gynecologic cancer who have received one or more prior lines of therapy. The primary endpoint is objective response rate. According to the trial registry, the study uses a Simon two-stage design and administers lorigerlimab intravenously on day 1 of every 21-day cycle; the specific dose level was not disclosed in the source material. To date, 41 participants have been dosed in the LINNET study, and MacroGenics reported that more than 300 participants have received lorigerlimab across all prior Phase I and Phase II studies. The data remain interim and are based on a subset of the planned enrollment; no efficacy data were reported in this announcement.
Lorigerlimab is a bispecific antibody in MacroGenics' proprietary DART (Dual-Affinity Re-Targeting) format that simultaneously targets PD-1 and CTLA-4, with the construct described in the peer-reviewed literature as a PD-1-guided CTLA-4 blocking molecule designed to activate antitumor T-cell responses. The partial hold, which preceded this lifting, followed a patient death reported in the study; the revised protocol addresses potential hematologic and cardiac toxicities identified during the hold period, though the company did not disclose the specific protocol amendments beyond characterizing them as additional risk-mitigation measures.
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