NICE has rejected to recommendation of using pembrolizumab as a first-line therapy for patients with untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma over concerns with cost-effectiveness and the effectiveness of the comparator drugs used in the KEYNOTE-048 trial, compared to their use in daily clinical practice. NICE have stated that more evidence showing the clinical benefit of pembrolizumab over extreme chemotherapy is needed to support this approval. 

The Institute of Cancer Research, London, has criticised this decision and is calling for an urgent reassessment of the evidence for the drug’s benefit.

The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust led the UK arm of a global clinical trial, KEYNOTE-048, showing that pembrolizumab used with chemotherapy or on its own extended survival compared with the standard ‘extreme’ chemotherapy currently used as a first treatment option.

As a result, the US Food and Drug Administration and the European Medicines Agency last year approved pembrolizumab as a first-line treatment for all head and neck cancers that are positive for an immune marker called PD-L1.

However, UK clinical practice differs from the rest of the world, in that the choice of first-line treatment varies depending on whether a person’s cancer started inside or outside the oral cavity.

In the UK, oral cavity cancers are treated with the ‘extreme’ cocktail of two chemotherapies plus a targeted drug, cetuximab, while other head and neck cancers are treated with just the two chemotherapies.

Professor Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, led the UK arm of the KEYNOTE-048 trial looking at the benefit of pembrolizumab as a first-line treatment for advanced head and neck cancer.

Professor Harrington said: “I’m deeply disappointed that pembrolizumab has not been recommended for use on the NHS, and that patients will have to wait even longer before they can access this immunotherapy as the first treatment of choice for advanced head and neck cancer. The decision by NICE brings the UK further out of step with clinical practice in the rest of the world, where cancers of the mouth are treated in the same way as other head and neck cancers."

“There is clear evidence that pembrolizumab has survival benefits for patients with head and neck cancer, and it is also a much kinder treatment than intensive chemotherapy. I would call on NICE to urgently revisit the evidence for the benefits of pembrolizumab, and to work with the drug company on a suitable compromise that makes this treatment available on the NHS as soon as possible, so patients in the UK will not have to face further delays in accessing it,” added Professor Harrington. 

Source: The Institute of Cancer Research