Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative status confers therapeutic sensitivity to Nab-paclitaxel, Pembrolizumab in patients with Invasive Breast Carcinoma.
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 statement is based on a regulatory approval from the European Medicines Agency:
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.