Merck has announced that Keytruda (pembrolizumab) has received the US FDA approval as monotherapy for patients expressing PD-L1 and as the first-line option for patient suffering from metastatic or with unresectable, recurrent head and neck squamous cell carcinoma in combination with platinum compounds and fluorouracil. Keytruda is the first PD-L1 inhibitor indicated for the two populations.
The approval is based on KEYNOTE-048 trial, in which Keytruda was compared with the EXTREME regimen. The primary endpoint is overall survival and profession-free survival. The median age of patients included in the study was 61 years. Treatment was continued until unacceptable toxicity or 24 months. The overall survival if Keytruda was indicated as a single agent was 12.3 months in Keytruda arm vs. 10.3 months in Cetuximab arm. In combination therapy, the overall survival was 13.0 months in Keytruda arm vs. 10.7 months in cetuximab + platinum + FU combination.
The most common adverse events were pneumonia, pneumonitis, and septic shock.