Rockville, Maryland-based MacroGenics reported updated interim results from its Phase 2 LINNET trial of lorigerlimab, an experimental immunotherapy for advanced gynecologic cancers, at the 2026 European Society for Medical Oncology (ESMO) Congress on October 26. Four of 16 evaluable patients with clear cell gynecologic cancer experienced confirmed tumor responses. The findings offer an early indication of activity in a difficult-to-treat disease, while the small patient group and earlier serious safety events leave important questions unresolved.
Four Patients Responded in the Clear Cell Cancer Cohort
Among 16 response-evaluable patients with clear cell gynecologic cancer, lorigerlimab produced a confirmed objective response rate of 25% and a disease control rate of 44%, or seven patients. All four confirmed responses were ongoing as of the September 1 data cutoff. Among 17 patients assessed for safety in that cohort, median progression-free survival was 2.9 months, with an estimated 33% progression-free at six months. The results are preliminary, and the single-arm study cannot establish whether lorigerlimab improves outcomes compared with standard care.
Earlier Safety Hold Remains Important Context
The study’s development has faced significant setbacks. In February, the FDA placed LINNET on partial clinical hold after serious safety events, including severe thrombocytopenia, myocarditis and a fatal episode involving neutropenia and septic shock. The hold was lifted in April after MacroGenics revised the protocol to add risk-mitigation measures. In the October analysis, 49% of the 41 patients treated across the clear cell and platinum-resistant ovarian cancer cohorts experienced grade 3 or higher treatment-related adverse events. Treatment-related events caused 24% to discontinue therapy, and one treatment-related death occurred in the platinum-resistant ovarian cancer cohort.
A Narrower Development Focus for Lorigerlimab
Lorigerlimab, previously called MGD019, is designed to target the immune checkpoints PD-1 and CTLA-4. The October data build on an earlier May 2026 update that had already reported four confirmed partial responses among 16 evaluable clear cell patients. That update also disclosed that the platinum-resistant ovarian cancer cohort had not met its predetermined response threshold, prompting MacroGenics to discontinue development for that indication. The latest ESMO presentation therefore represents additional follow-up on a more focused clinical program, rather than the first disclosure of the 25% response rate.
Lower-Dose Expansion Will Test the Next Step
MacroGenics is enrolling 20 additional patients with clear cell gynecologic cancer at a lower dose of 3 mg/kg every three weeks, compared with the 6 mg/kg dose used in the reported cohorts. The company expects to share updated results in the first half of 2027. For Maryland’s life sciences community, the trial illustrates both the promise and difficulty of advancing locally developed cancer therapeutics: the next dataset will be important for judging whether activity can be maintained with a more acceptable safety profile.
