Agenus Reports More Than Half of Patients with Refractory MSS Metastatic Colorectal Cancer Achieved Long-Term Survival Following BOT+BAL Treatment at SITC 2026
Key Highlights
- ➤51% of patients (63/123) survived at least 18 months after starting BOT+BAL
- ➤Long-term survivors had 59% estimated three-year survival; median overall survival unreached
- ➤35% of long-term survivors achieved confirmed tumor responses, including three complete responses
- ➤24% of long-term survivors were alive and off all anticancer treatment at follow-up
- ➤No treatment-related deaths were observed in the analysis
Expert Statements
Thomas U. Marron, MD, PhD, Tisch Cancer Center at Mount Sinai; presenting author
“For patients with metastatic MSS colorectal cancer without active liver metastases who have exhausted multiple therapies, living another year and a half or more is rare.”
Thomas U. Marron, MD, PhD, Tisch Cancer Center at Mount Sinai; presenting author
“What is particularly interesting is that the long-term survivors did not fit a single favorable clinical profile.”
Thomas U. Marron, MD, PhD, Tisch Cancer Center at Mount Sinai; presenting author
“Durable benefit was seen even in patients previously treated with immunotherapy, and a subset remains alive without any further cancer treatment.”
Thomas U. Marron, MD, PhD, Tisch Cancer Center at Mount Sinai; presenting author
“These findings suggest the potential to meaningfully change the course of disease and provide a compelling rationale for evaluating this approach earlier in treatment.”
Steven J. O’Day, MD, Chief Medical Officer of Agenus
“The significance of these data extends beyond the survival milestone itself.”
Steven J. O’Day, MD, Chief Medical Officer of Agenus
“Deep responses and durable disease control in heavily pretreated, immunologically cold tumors reinforce the potential of BOT’s differentiated Fc-enhanced immune-priming approach.”
Steven J. O’Day, MD, Chief Medical Officer of Agenus
“The association between fewer prior therapies and long-term survival strengthens the rationale for evaluating BOT+BAL earlier in the course of disease.”
Steven J. O’Day, MD, Chief Medical Officer of Agenus
“This is central to our Phase 3 ROBBIN strategy, which is designed to evaluate a short course of BOT+BAL before surgery in high-risk MSS colon cancer, with the goal of reducing recurrence, de-escalating the need for chemotherapy and increasing the potential for cure.”
Agenus Reports More Than Half of Patients with Refractory MSS Metastatic Colorectal Cancer Achieved Long-Term Survival Following BOT+BAL Treatment at SITC 2026
* Long-term survival of patients in the 123-patient Phase 1b CRC cohort was not limited to patients with favorable baseline characteristics, suggesting durable benefit may extend across a broader patient population
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