Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Paclitaxel, Pembrolizumab in patients with Ovarian Epithelial Tumor.

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 with a CPS >= 1 and who have received one or two prior systemic treatment regimens.

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

KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS >= 1 and who have received one or two prior systemic treatment regimens.

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.