KEYNOTE-048 has met a primary end point of overall survival.
This article originally appeared on The American Journal of Managed Care.
KEYNOTE-048, a phase 3 trial studying pembrolizumab (Keytruda) as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress PD-L1, has met
a primary end point of overall survival.
The study, a phase 3 randomized, open-label trial is designed to investigate pembrolizumab as a first-line monotherapy or in combination with either a platinum chemotherapy (cisplatin or carboplatin) plus 5-flurouracil (5-FU) compared with cetuximab with platinum chemotherapy plus 5-FU, the current standard of care for first-line HNSCC treatment. The dual primary end points were overall survival and progression-free survival.
About 825 patients were enrolled in the study and randomly assigned to receive:
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