Agenus’ BOT+BAL Delivers 33% Three-Year Survival in MSS Metastatic Colorectal Cancer
AGEN•Agenus’ immunotherapy combination BOT+BAL achieved a 33% three-year overall survival rate in refractory microsatellite-stable metastatic colorectal cancer patients without active liver metastases in ESMO GI 2026 data. The landmark result marks a potential advancement over historical benchmarks and could accelerate Agenus’ clinical and regulatory progress.
1. Data Presentation at ESMO GI 2026
Agenus unveiled BOT+BAL results during ESMO GI 2026, highlighting immunotherapy activity in refractory microsatellite-stable metastatic colorectal cancer. This high-profile oncology congress provided a platform to showcase the three-year overall survival outcome without focusing on patients with active liver metastases.
2. Study Design and Patient Cohort
The analysis involved patients with refractory MSS metastatic colorectal cancer who had no active liver involvement. The single-arm study evaluated safety and efficacy of combining the anti-CTLA-4 and anti-PD-1 antibodies over a median follow-up period of more than three years.
3. Efficacy Results and Benchmark Comparison
The BOT+BAL regimen achieved a 33% overall survival rate at three years, outperforming historical MSS colorectal cancer benchmarks of less than 10%. Responses were durable, with a subset of patients maintaining disease control beyond 36 months.
4. Implications and Next Steps
These findings could support a pivotal trial design and bolster discussions with regulatory agencies. Agenus plans to advance BOT+BAL into larger randomized studies and explore potential accelerated approval pathways based on survival benefit.
