MacroGenics announced that the U.S. Food and Drug Administration has placed a partial clinical hold on its Phase 2 LINNET study evaluating lorigerlimab, a bispecific antibody designed to target PD-1 and CTLA-4 for the treatment of gynecologic cancers. The regulatory action restricts enrollment of new study participants while the company and FDA assess safety data from the ongoing trial.
The clinical hold was issued following the occurrence of serious adverse events in four patients enrolled in the study. The reported safety concerns include Grade 4 thrombocytopenia, myocarditis, neutropenia complicated by septic shock, and one patient death. These events prompted the FDA to take precautionary action to evaluate the benefit-risk profile of the investigational therapy.
Under the terms of the partial clinical hold, MacroGenics will cease enrollment of new participants in the LINNET trial, though existing study subjects may continue their current treatment regimens pending further guidance. The company is working with the FDA to address the safety findings and determine the conditions necessary for resuming patient enrollment in the study.