European Commission approves Keytruda for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma . Merck Inc.

Merck Inc., has 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 tumors express PD-L1 (combined positive score [CPS] ?1). This approval is based on findings from the pivotal Phase III 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 tumors expressed PD-L1 (CPS ?1).

�This disease is especially debilitating since it can be highly visible and affect a patient�s appearance and their daily functions, such as eating and speaking,� said Professor Kevin Harrington, investigator for KEYNOTE-048, professor of biological cancer therapies at The Institute of Cancer Research, London, and consultant clinical oncologist at The Royal Marsden NHS Foundation Trust. �Considering the great need for new treatment options, we are encouraged by the Keytruda approval in Europe, which will allow certain patients to be treated with immunotherapy earlier in the course of their treatment.�