NICE rejects Keytruda as a treatment of head and neck cancer.-Merck Inc.

The National Institute for Health and Care Excellence (NICE) has published a new draft guidance not recommending Keytruda (pembrolizumab) from Merck Inc., for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). NICE requires an urgent reassessment of the evidence for the drug’s benefit, and has asked for more clinical and cost-effectiveness evidence from Merck Inc,. Evidence from the KEYNOTE-048 trial showed that some patients who have a type of metastatic or unresectable recurrent HNSCC – defined as PD-L1 positive, with a combined positive score of one or more – lived longer longer when treated with Keytruda. However, NICE has said that the uncertainty over the drug lies in the evidence, because the comparator drugs in the trial do not reflect what currently happens in practice in the NHS in England.