Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER negative, HER2-negative, PR negative status confers therapeutic sensitivity to Carboplatin, Cyclophosphamide, Doxorubicin, Paclitaxel, Pembrolizumab in patients with Invasive Breast Carcinoma.
The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy for the neoadjuvant treatment, and then pembrolizumab continued as a single agent as adjuvant treatment after surgery, of patients with high-risk early-stage triple negative breast cancer (TNBC). This indication is based on KEYNOTE-522 (NCT03036488), a randomized (2:1), multicenter, double-blind, placebo-controlled trial where the chemotherapy regimen consisted of carboplatin, paclitaxel, doxorubicin, and cyclophosphamide.
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 for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.