Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that dMMR status confers therapeutic sensitivity to Pembrolizumab in patients with Endometrial Carcinoma.

The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the treatment of adult patients with microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR) advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation.

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

KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation.

Citation

Merck Sharp & Dohme B.V. Keytruda (pembrolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Revised January 2024. Accessed March 10, 2024.