The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of pembrolizumab (Keytruda) for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who progressed following platinum-based chemotherapy and have a PD-L1 tumor proportion score (TPS) ≥50%.
Randomization was stratified by ECOG performance status (0 vs 1), known p16 status for cancer of the oropharynx, and PD-L1 TPS (≥50% vs <50%).The results were also analyzed according to combined positive score (CPS).
Treatment continued until confirmed disease progression or intolerable toxicity. The primary endpoint was overall survival (OS) in the intent-to-treat population. The one-sided prespecified efficacy boundary was an alpha of 0.0175, corresponding to a hazard ratio of 0.80.
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