The Absolute Effect / Evidence index

Neoadjuvant · Phase II sequential non-randomized cohorts; N=56 resectable locally advanced pMMR/dMMR colon cancer. Neoadjuvant botensilimab alone or botensilimab+balstilimab. Primary endpoint centrally assessed pMR. · pMR: pMMR BOT 0%

UNICORN

Clinical question: Can neoadjuvant botensilimab, with or without balstilimab, induce major pathological response in resectable pMMR or dMMR colon cancer?

pMR: pMMR BOT 0%; pMMR BOT+BAL 36%; dMMR BOT 36%; dMMR BOT+BAL 100%. 12-month EFS 93%, 100%, 79%, 100% across reported cohorts. · Registry:

Design, population and treatment

Phase II sequential non-randomized cohorts; N=56 resectable locally advanced pMMR/dMMR colon cancer. Neoadjuvant botensilimab alone or botensilimab+balstilimab. Primary endpoint centrally assessed pMR.

Key efficacy outcome

100 · intervention
36
100 · comparator
No NNT: sequential non-randomized cohorts and no causal comparator.

Immune-related AEs occurred in 29% with BOT and 54% with BOT+BAL; mostly flu-like syndrome and diarrhoea.

Safety and absolute effect

pMR rate (%)

https://www.nature.com/articles/s41591-026-04710-1

Interpretation and limitations

Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.

Primary source

Primary publication · DOI: 10.1038/s41591-026-04710-1