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Agenus Reports 72% of Patients with Locally Advanced dMMR Colon Cancer Had No Cancer Remaining at Surgery Following Six Weeks of BOT+BAL in Phase 2 NEOASIS Study at ESMO 2026

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  • The cohort met its primary endpoint of major pathologic response, with 83% of patients having little or no cancer remaining at surgery in a high-risk, locally advanced population

  • Side effects were mostly mild and manageable, and all 18 patients proceeded to surgery

  • Netherlands Cancer Institute investigators are now enrolling a rectal cancer cohort to evaluate whether a short course of botensilimab and balstilimab can allow patients to avoid surgery

LEXINGTON, Mass., October 25, 2026--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced early Phase 2 results from the mismatch repair-deficient (dMMR) colon cancer cohort of NEOASIS, an investigator-initiated pan-tumor study sponsored by the Netherlands Cancer Institute (NKI). NEOASIS is evaluating botensilimab (BOT), Agenus' multifunctional, Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), Agenus' anti-PD-1 antibody, given before surgery (neoadjuvant) in patients with solid tumors. The results were presented in a poster at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

The cohort met its primary endpoint, with 83% of 18 patients achieving a major pathologic response (MPR), defined as 10% or less viable tumor remaining at surgery, and 72% achieving a pathologic complete response (pCR), with no cancer remaining in the tumor or nearby lymph nodes.

These results were achieved in patients at the highest risk of their cancer returning. All patients had locally advanced colon cancer, and 100% of tumors were at least T3. Two-thirds (67%) were T4 tumors that had grown through the bowel wall. Nearly three-quarters (72%) had cancer that had spread to nearby lymph nodes. Treatment was a short 6-week course of immunotherapy alone with one 50 mg dose of BOT and two 450 mg doses of BAL, given three weeks apart, followed by surgery within eight weeks.

For patients with locally advanced dMMR colon cancer, treatment today typically begins with surgery, followed by months of chemotherapy that may be combined with up to a year of PD-L1 immunotherapy. NEOASIS is evaluating a different approach, giving a short course of immunotherapy before surgery while the tumor and surrounding lymph nodes are still in place to help drive an immune response against cancer.

"Nearly three out of four patients with locally advanced disease, had no cancer remaining at surgery after a single dose of botensilimab and two doses of balstilimab," said Myriam Chalabi, MD, PhD, principal investigator of the NEOASIS study at the Netherlands Cancer Institute. "These dMMR colon cancer results build on the responses we first reported across multiple tumor types in NEOASIS and support continued investigation of BOT+BAL before surgery. Our ongoing rectal cancer cohort is exploring whether deep responses like these, with a short duration of neoadjuvant BOT+BAL, can allow selected patients to preserve their organs and quality of life without compromising cancer outcomes."

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