MacroGenics Announces Pausing of Enrollment of New Study Participants in LINNET Trial

Core Viewpoint - The FDA has placed a partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab, affecting new patient enrollment due to recent safety events [1][2]. Group 1: FDA Clinical Hold - The partial clinical hold was initiated after MacroGenics notified the FDA of a temporary pause in enrollment due to safety events involving four patients, including Grade 4 thrombocytopenia (2 patients), Grade 4 myocarditis (1 patient), and Grade 4 neutropenia with concurrent septic shock leading to a Grade 5 event (1 patient) [2]. - No new patients will be enrolled in the LINNET study until the hold is lifted, but current participants can continue receiving the study drug [1][2]. Group 2: LINNET Study Details - The LINNET study evaluates lorigerlimab, a bispecific DART® molecule targeting PD-1 and CTLA-4, as monotherapy in patients with platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancer (CCGC) [3]. - The study is designed as a Simon two-stage trial, initially enrolling approximately 20 patients, with the potential to expand to an additional 20 patients if a predefined activity threshold is met [3]. - The primary endpoint of the study is the objective response rate (ORR), with multiple secondary endpoints [3]. Group 3: Company Overview - MacroGenics is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for cancer treatment [4]. - The company generates its pipeline from proprietary next-generation antibody-based technology platforms, enabling strategic collaborations with global pharmaceutical and biotechnology companies [4].