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 Carboplatin, Gemcitabine, Pembrolizumab in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the Food and Drug Administration:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS >=10) as determined by an FDA approved test.