Keytruda Succeeds in Phase 3 Trial for Head and Neck Cancer

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:

• Pembrolizumab as a monotherapy at 200mg administered intravenously on day 1 of each week in 3-week cycles for up to 24 months
• Pembrolizumab at 200mg, administered intravenously on day 1 of each week in 3-week cycles for up to 24 months plus a platinum chemotherapy (investigators choice) on day 1 of each week in 3-week cycles (6-cycle maximum); plus 5-FU at 1000mg/m²per day, intravenously, continuous from day 1-4 of each 3-week cycle (6-cycle maximum)
• Cetuximab on day 1 at a dose of 400mg, and then 250mg on day 1 of each week until disease progression or unacceptable toxicity; plus a platinum chemotherapy on day 1 of each week in 3-week cycles (6-cycle maximum); plus 5-FU at 1000mg/m²per day, intravenously, continuous from day 1-4 of each 3-week cycle (6-week cycle maximum)

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