Dr. Rischin on KEYNOTE-048 Results in Head and Neck Squamous Cell Carcinoma

Danny Rischin, MD, director, Division of Cancer Medicine, head, Department of Medical Oncology, Peter MacCallum Cancer Centre, discusses the phase III KEYNOTE-048 trial, which examines pembrolizumab (Keytruda) or pembrolizumab plus chemotherapy versus EXTREME as first-line therapy for patients with recurrent/metastatic head and neck squamous cell carcinoma.

The regimens were investigated in 3 populations: patients who had a PD-L1 combined positive score (CPS) of ≥20 and ≥1, and in the overall population. Pembrolizumab monotherapy versus EXTREME showed significantly improved OS in patients with PD-L1 CPS ≥20 and CPS ≥1. In the total population, pembrolizumab monotherapy showed no PFS improvements and was noninferior, but it did not meet the superiority threshold. Response rates were lower with pembrolizumab monotherapy versus EXTREME in the overall population, but the duration of response was longer. The adverse event (AE) profile showed that there were less serious AEs in patients who received pembrolizumab monotherapy.

The pembrolizumab plus chemotherapy combination versus EXTREME also improved overall survival in all 3 populations. The pembrolizumab monotherapy and combination arms had similar response rates, PFS, and AE profiles.