The FDA removed the partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab, allowing the company to resume enrollment of new participants in the gynecologic cancer trial.
Key takeaways
The FDA removed the partial clinical hold on the Phase 2 LINNET study of lorigerlimab, an investigational bispecific DART molecule targeting PD-1 and CTLA-4.
MacroGenics intends to resume enrollment of new study participants in the ongoing LINNET study under a revised protocol with additional risk-mitigation measures.
The LINNET study is evaluating lorigerlimab in up to approximately 60 patients with platinum-resistant ovarian cancer or clear cell gynecologic cancer who have received prior therapy.
To date, 41 study participants have been dosed in the LINNET study, and over 300 participants have been dosed across all previous lorigerlimab Phase 1 and Phase 2 studies.
The company remains on track to provide a mid-year clinical update on the lorigerlimab program.