5 August 2016 - Merck today announced that the U.S. FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. 

Under the FDA’s accelerated approval regulations, this indication for Keytruda is approved based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. For head and neck squamous cell carcinoma (HNSCC) patients, PD-L1 testing is not needed prior to use of Keytruda.

The approval is based on data from the KEYNOTE-012 study, which included patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy and ECOG performance status of zero or one. The data showed an objective response rate (ORR) of 16% (95% CI: 11, 22), complete response rate of 5%, with responses of six months or longer observed in 82% (n=23/28) of the responding patients. ORR and duration of response were similar regardless of human papilloma virus status.

Read Merck press release