Roger Dansey, MD
Pembrolizumab (Keytruda) did not meet the primary endpoint of overall survival (OS) in patients with previously-treated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in the phase III KEYNOTE-040 trial, according to Merck, the manufacturer of the PD-1 inhibitor.
The company did not say what significance, if any, these results might have for KEYNOTE-048, a phase III trial comparing pembrolizumab with platinum-based chemotherapy plus 5-FU and cetuximab, or in combination with platinum-based therapy and 5-FU as a frontline treatment for patients with recurrent or metastatic HNSCC.
Mehra R, Seiwert TY, Mahipal A, et al. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Pooled analyses after long-term follow-up in KEYNOTE-012. J Clin Oncol. 2016;34 (suppl; abstr 6012).
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