Therapeutic Response

ER negative, HER2-negative, PD-L1 (CPS) >= 10, and PR negative status confers therapeutic sensitivity to Paclitaxel in combination with Pembrolizumab in patients with Invasive Breast Carcinoma.

Statements

Source and description
Keytruda (pembrolizumab) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (CPS >= 10), as determined by an FDA approved test. This indication is based on KEYNOTE-355 (NCT02819518), a multicenter, double-blind, randomized, placebo-controlled trial where patients received either paclitaxel and paclitaxel protein-bound, or gemcitabine and carboplatin.
Keytruda (pembrolizumab) [product information]. EMA. 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.