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 High-Grade Serous Fallopian Tube Cancer.

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.