Therapeutic Response

PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Carboplatin in combination with Paclitaxel and Pembrolizumab in patients with Cervical Adenocarcinoma.

Statements

Source and description
Keytruda (pembrolizumab) [package insert]. FDA. 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.
Keytruda (pembrolizumab) [product information]. EMA. The European Medicines Agency (EMA) has authorized pembrolizumab in combination with chemotherapy and with or without bevacizumab for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 with a combined positive score (CPS) >= 1. This indication is based on KEYNOTE-826, a multicenter, randomized, double-blind, and placebo-controlled study that studied the efficacy of pembrolizumab in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab in 617 patients meeting this indication's clinical criteria.