MSS colon cancer remains one of the most challenging areas in immuno-oncology, with limited benefit from conventional checkpoint inhibitors. Agenus is aiming to address this unmet need through botensilimab plus balstilimab (BOT+BAL), a dual immunotherapy combination designed to activate broader antitumor immune responses in tumors that have historically been resistant to immunotherapy.
Following promising signals from the NEST and UNICORN Phase 2 studies, Agenus is advancing the registrational Phase 3 ROBBIN trial to evaluate neoadjuvant BOT+BAL in previously untreated high-risk Stage II and Stage III MSS colon cancer.
Dr. Steven O’Day, Chief Medical Officer of Agenus, said:
“We have seen neoadjuvant and perioperative immunotherapy improve outcomes in immunologically ‘hot’ or ‘warm’ tumors such as melanoma and lung cancer, but MSS colon cancer — a ‘cold’ tumor — has resisted standard checkpoint inhibitors. BOT was engineered to overcome that resistance and has produced deep pathologic responses with no recurrences reported in the NEST and UNICORN studies. With the ROBBIN trial, we are bringing this regimen to patients with high-risk Stage II and Stage III MSS colon cancer, where treating an intact tumor gives BOT+BAL its greatest opportunity to generate a durable immune response and improve long-term outcomes.”
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