Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that MSI-H status confers therapeutic sensitivity to Ipilimumab, Nivolumab in patients with Colorectal Adenocarcinoma.

This statement is based on a regulatory approval from the European Medicines Agency:

OPDIVO in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.

Citation

Bristol-Myers Squibb Pharma EEIG. Opdivo (nivolumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf. Revised June 2025. Accessed September 5, 2025.