A timely lift for MacroGenics

After several setbacks, some relating to its now main project lorigerlimab, MacroGenics is moving forward again, even though questions remain. The US FDA has lifted a partial clinical hold on the phase 2 Linnet trial, allowing the company to continue developing the abti-PD-1 x CTLA-4 bispecific MAb for gynaecological cancers. The hold, which began in February, was due to serious toxicity issues: four grade 4 or higher adverse events occurred among 41 patients, including two cases of thrombocytopenia, one of myocarditis, and one fatal neutropenia with septic shock. MacroGenics has now updated the study protocol to include enhanced monitoring and measures to reduce risks of blood and heart problems. New patients will join the study under these changes, and the company still plans to share a clinical update by mid-2026, but these toxicity issues don't look promising for the study's overall outcome. The Linnet study is now the only company-sponsored trial of lorigerlimab. Last November MacroGenics stopped developing the asset for prostate cancer after deciding that the Lorikeet study was unlikely to show improved radiographic progression-free survival. Despite that setback, the company continued Linnet, in platinum-resistant ovarian and clear cell gynaecological cancers.