Posted by Michael Wonder on 20 Nov 2019
European Commission approves two new regimens of Merck’s Keytruda (pembrolizumab) as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma
20 November 2019 - Approval based on significant overall survival findings from Phase 3 KEYNOTE-048 trial.
Merck today announced that the European Commission has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 (combined positive score [CPS] ≥1).
This approval is based on findings from the pivotal Phase 3 KEYNOTE-048 trial, in which Keytruda, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), demonstrated a significant improvement in overall survival (OS) as monotherapy (HR = 0.74 [95% CI, (0.61-0.90); p=0.00133] and in combination with chemotherapy (HR=0.65 [95% CI, 0.53-0.80]; p=0.00002), in patients whose tumours expressed PD-L1 (CPS ≥1).
