Agenus Reports Landmark BOT+BAL Data Showing 33% Three-Year Overall Survival in Refractory MSS Metastatic Colorectal Cancer Without Active Liver Metastases at ESMO GI 2026
- Fully enrolled 123-patient Phase 1b cohort demonstrated 21.2-month median overall survival, 33% three-year overall survival, and a survival curve plateau beyond two years
- Data presented in a heavily pretreated population where durable long-term survival is rarely reported
- 17% of patients alive and off all systemic anticancer therapy at last follow-up
- Extended safety follow-up showed no new safety signals, no treatment-related deaths, and 98% resolution of immune-mediated diarrhea/colitis
Excerpt from the Press Release:
LEXINGTON, Mass.–(BUSINESS WIRE)–Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced three-year landmark Phase 1b data from the fully enrolled C-800-01 cohort evaluating botensilimab (BOT), an Fc-enhanced multifunctional anti–CTLA-4 antibody, plus balstilimab (BAL), an anti–PD-1 antibody, in patients with refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. The data were presented at the European Society for Medical Oncology Gastrointestinal Cancers (ESMO GI) Congress 2026 on July 2 in Munich, Germany.
BOT+BAL demonstrated clinically meaningful long-term survival in a heavily pretreated patient population with historically limited benefit from conventional immune checkpoint inhibitors and few durable treatment options after progression on standard therapies. With extended follow-up, median overall survival was 21.2 months and the three-year overall survival rate was 33%, with the Kaplan-Meier curve showing a plateau beyond two years.
Available later-line standards in refractory MSS mCRC without active liver metastases have historically reported median overall survival of approximately 10–14 months in relevant analyses, reflecting a treatment setting in which few patients have historically remained alive at later landmark timepoints and pivotal studies have generally focused on median survival rather than mature 36-month overall survival outcomes.i
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