11 June 2019 - Keytruda now approved for first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma as monotherapy for patients whose tumours express PD-L1 (CPS ≥1) or in combination with platinum and 5-fluorouracil regardless of PD-L1 rxpression.

Merck today announced that the U.S. FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy in patients whose tumours express PD-L1 (Combined Positive Score [CPS] ≥1) or in combination with platinum and fluorouracil (FU), a commonly used chemotherapy regimen, for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma. 

The approval is based on results from the pivotal Phase 3 KEYNOTE-048 trial, where Keytruda demonstrated a significant improvement in overall survival compared with the EXTREME regimen (cetuximab with carboplatin or cisplatin plus FU), a standard treatment, as monotherapy in patients whose tumours expressed PD-L1 (CPS ≥1) (HR=0.78 [95% CI, 0.64-0.96]; p=0.0171) and in combination with chemotherapy in the total study population (HR=0.77 [95% CI, 0.63-0.93]; p=0.0067).

Read Merck press release