Keytruda cleared for NHS use in early head and neck cancer

MSD's Keytruda is poised to end a 20-year drought in new advances in NHS treatment for early-stage head and neck cancer, after being recommended by reimbursement authority NICE.

In final draft guidance (PDF), NICE has said that Keytruda (pembrolizumab) can be used within NHS England as a treatment for patients with locally advanced head and neck squamous cell carcinoma (LA HNSCC) who are candidates for surgery and whose tumours have a PD-L1 biomarker combined score of 1 or more.

The decision covers perioperative use of the PD-1 inhibitor, with two cycles of the drug given before surgery and 15 cycles after surgery added to standard care, including post-surgery radiotherapy and, in some cases, chemotherapy. Keytruda was shown to improve event-free survival (EFS) when used this way in the KEYNOTE-689 trial.

"There is enough evidence to show that pembrolizumab provides benefits and value for money, so it can be used routinely across the NHS in this population," said NICE in its guidance.

"Clinical trial evidence shows that neoadjuvant and adjuvant pembrolizumab increases how long people have before their condition gets worse. The evidence also suggests that it may increase how long people live compared with usual treatment," according to the document, which sets the clock ticking on a 90-day implementation period for NHS funding of Keytruda in this setting.

NICE's guidance is the first recommendation for perioperative immunotherapy for LA HNSCC, and makes Keytruda the first new therapy to show an improvement over standard care for two decades, according to MSD. Keytruda has been used by the NHS to treat advanced, PD-L1-positive HNSCC in people unable to have surgery since 2020.

Head and neck cancer is the ninth most common cancer in the UK, with 12,800 new diagnoses annually and HNSCC, accounting for around 90% of all cases. Around two-thirds of patients are diagnosed when they have locally advanced disease.

Treatment options for LA HNSCC can be effective but put patients at risk of impairing their ability to speak, swallow, breathe, see, smell and taste, as well as their mental health and personal appearance. Head and neck cancer patients face a risk of suicide, which is around three times higher than the general population, according to MSD.

"This recommendation is an important moment for people living with head and neck cancer in England," said Tamara Kahn, chair of the Head and Neck Cancer Coalition advocacy organisation.

"Treatment can be gruelling, and many people are left dealing with lasting challenges in speaking, eating and everyday interaction long after treatment ends," she added. "For the head and neck cancer community, this brings real hope, not just in treating the cancer but in the possibility that fewer people may face the most severe long-term effects after treatment."