MacroGenics, Inc. said the U.S. Food and Drug Administration lifted the partial clinical hold on its Phase 2 LINNET study of lorigerlimab, allowing enrollment to resume under a revised protocol with added safety mitigation measures.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
MacroGenics, Inc. announced that the U.S. Food and Drug Administration has lifted the partial clinical hold on the Phase 2 LINNET study evaluating lorigerlimab, an investigational bispecific DART® molecule targeting PD-1 and CTLA-4, in gynecologic cancers. The hold previously allowed participants already enrolled to continue treatment, while enrollment of new patients was paused.
The partial clinical hold, imposed in late February 2026, followed MacroGenics’ report of serious safety events in four patients, including Grade 4 thrombocytopenia (two cases), Grade 4 myocarditis, and Grade 4 neutropenia with septic shock resulting in one fatal event. At the time, 41 patients with platinum-resistant ovarian cancer and clear cell gynecologic cancer had been dosed, and while enrollment was paused, previously enrolled participants were allowed to continue treatment.
Eric Risser, President and Chief Executive Officer of MacroGenics, said the company worked closely with the FDA and submitted a comprehensive response to address the agency’s concerns. He added that enrollment in the LINNET study is expected to resume and the company remains on track to provide a mid-year clinical update.
The Phase 2 LINNET study is evaluating single-agent lorigerlimab in approximately 60 patients with 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, with multiple secondary endpoints assessing clinical activity and safety.
To date, 41 participants have been dosed in the LINNET study. Across earlier Phase 1 and Phase 2 trials, more than 300 patients have received lorigerlimab.
Reference
FDA Removes Partial Clinical Hold on MacroGenics’ LINNET Study, 08 April 2026, https://ir.macrogenics.com/news-releases/news-release-details/fda-removes-partial-clinical-hold-macrogenics-linnet-study
About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.