On June 10, the Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) in the first-line setting as monotherapy for patients whose tumors express PD-L1 or in combination with platinum and fluorouracil regardless of PD-L1 expression for patients with metastatic or unresectable, recurrent HNSCC.
Approval was based on KEYNOTE-048, a trial of 882 people with advanced head and neck squamous cell carcinoma who had not received prior therapy. PD-L1 positive patients were randomized into 3 arms (1: 1: 1) to receive the following regimens: pembrolizumab alone, pembrolizumab + QT (carboplatin or cisplatin and FU) or cetuximab + QT.
Overall survival (OS) was significantly improved in the pembrolizumab + QT arm compared to cetuximab + QT, with a median of 13 months versus 10.7.
At the time of analysis, there was no significant difference in OS between pembrolizumab alone and cetuximab + QT, and in progression-free survival (PFS) between treatments with pembrolizumab compared to cetuximab + QT.
The most common side effects are fatigue, pain, decreased appetite, itching, rash, diarrhea, nausea, fever, cough, shortness of breath, and constipation. Access the article here.