Japan’s Pharmaceuticals and Medical Devices Agency has granted approval to frontline pembrolizumab as monotherapy and in combination with chemotherapy for the treatment of patients with recurrent or distant metastatic head and neck cancer.1
The approval for pembrolizumab in both indications is based on findings from the phase III KEYNOTE-048 trial, which evaluated the PD-1 inhibitor alone and in combination with platinum-based therapy and 5-fluorouracil (5-FU) compared with standard cetuximab (Erbitux) with platinum-based therapy plus 5-FU in patients with recurrent or metastatic head and neck squamous cell carcinoma.
The combination of pembrolizumab plus chemotherapy demonstrated a 23% reduction in the risk of death versus standard therapy (HR, 0.77; 95% CI, 0.63-0.93; P
Moreover, single-agent pembrolizumab demonstrated noninferiority compared with the standard regimen (HR, 0.85; 95% CI, 0.71-1.03; P
= .00014), and it also demonstrated a statistically significant improvement in OS in patients with PD-L1–positive (combined positive score [CPS] ≥1) tumors versus standard therapy.
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