Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with chemotherapy for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 with a combined positive score (CPS) >= 10 and who have not received prior chemotherapy for metastatic disease. This indication is based on KEYNOTE-355, a phase 3, randomizewd, double-blind, multi-center, placebo-controlled study where the efficacy of pembrolizumab in combination with: (i) paclitaxel, (ii) nab-paclitaxel, or (iii) gemcitabine and carboplatin were investigated for the treatment of patients with TNBC who were previously untreated for metastatic disease.

This is written in the approval document as:

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS >= 10 and who have not received prior chemotherapy for metastatic disease.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Paclitaxel, Pembrolizumab
Sensitivity (+)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Nab-paclitaxel, Pembrolizumab
Sensitivity (+)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Carboplatin, Gemcitabine, Pembrolizumab