Neoadjuvant botensilimab with or without balstilimab in pMMR and dMMR colon cancer: the phase 2 UNICORN trial
Ghelardi F … Pietrantonio F. Nature Medicine.
Take-home. Preoperative botensilimab plus balstilimab demonstrates promising activity in both pMMR and dMMR colon cancer, potentially expanding immunotherapy benefits to patients previously considered resistant to checkpoint inhibition.
The phase 2 UNICORN trial investigated preoperative botensilimab (BOT), alone or combined with balstilimab (BAL), in 56 patients with locally advanced colon cancer. The combination achieved major pathological responses in both pMMR (36%) and dMMR (100%) tumors, whereas BOT alone showed limited activity in pMMR disease. Immune-related adverse events occurred, while ctDNA clearance correlated with pathological response and absence of recurrence.






