Agenus presents Phase 3 trial plans for BOT+BAL in MSS colon cancer
AGEN•Agenus plans to start its 850-patient Phase 3 ROBBIN trial of botensilimab and balstilimab in MSS colon cancer by Q1 2027, with event-free survival as the primary endpoint. The company expects interim analysis in the second half of 2029 and says PIPE financing could cover costs through year-end 2031, assuming full warrant exercise.
1. ROBBIN trial plans
Agenus plans to start its FDA-aligned Phase 3 ROBBIN trial of neoadjuvant botensilimab and balstilimab in MSS colon cancer by Q1 2027. The trial will enroll 850 patients, with event-free survival as its primary endpoint; interim analysis is anticipated in the second half of 2029, and final analysis in the second half of 2030.
2. Earlier patient results
Across the NEST and UNICORN studies, roughly 30% of 34 MSS patients achieved complete pathological responses. No recurrences occurred among all 52 patients treated with the combination. Agenus said PIPE financing is expected to cover ROBBIN costs and operating expenses through year-end 2031, assuming full warrant exercise.
