Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that MSI-L status confers therapeutic sensitivity to Lenvatinib, Pembrolizumab in patients with Endometrial Carcinoma.

The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

This statement is based on a regulatory approval from the Food and Drug Administration:

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125514s174lbl.pdf. Revised April 2025. Accessed April 30, 2025.