NICE reverses earlier negative decision on Keytruda for first-line use in adults with HNSCC

UK health technology assessor the National Institute for Health and Care Excellence (NICE) has reversed a draft rejection of Keytruda (pembrolizumab) and now recommends the monotherapy for the first-line treatment of adults with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 with a combined positive score (CPS) of one or more, according to the UK subsidiary of US pharma giant Merck & Co (NYSE: MRK), known as MSD outside the USA and Canada.

Pembrolizumab is only recommended if it is stopped at two years of uninterrupted treatment, or earlier if disease progresses and if the company provides pembrolizumab according to the commercial arrangement. The NICE’s recommendation is not intended to affect treatment with pembrolizumab that was started in the NHS prior to the publication of this guidance. This announcement means pembrolizumab is the first checkpoint inhibitor to be made available for first-line use to PD-L1 positive adults with this type of cancer. Suitable patients now have an additional choice of treatment for a cancer which currently has limited options. The announcement gives clinicians more opportunity to develop treatment plans aligned to their patient’s individual clinical needs.

While there are many different types of head and neck cancer, HNSCC is the most common form. About nine out of 10 head and neck cancers start in squamous cells. Within HNSCC, patients with metastatic or unresectable recurrent HNSCC tend to have a poor prognosis and median overall survival in most cases is six to 15 months. Therefore, it is very important for people to talk to their healthcare professional as soon as symptoms present to increase the chance of earlier detection. In the UK, there are around 12,200 new head and neck cancer cases every year and it is the eighth most common cancer in the overall population, rising to the fourth most common for men. Higher incidence rates have a marked link to deprivation. Over the last decade, head and neck cancer incidence rates have increased by 20% in the UK and mortality by almost 16%.