Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab in patients with Cervical Adenocarcinoma.
The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy with or without bevacizumab for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1), as determined by an FDA-approved test. This indication is based on KEYNOTE-826 (NCT03635567), a multicenter, randomized, double-blind, placebo-controlled trial where patients received one of the following as the chemotherapy portion of their treatment regimen: cisplatin and paclitaxel; bevacizumab, cisplatin, and paclitaxel; carboplatin and paclitaxel; bevacizumab, carboplatin, and paclitaxel.
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, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.