The ICR responds to decision by NICE not to recommend pembrolizumab as first-line treatment for advanced head and neck cancer

The Institute of Cancer Research, London, has criticised the decision by NICE not to recommend the immunotherapy, pembrolizumab, as a first-line treatment for patients with advanced head and neck cancer 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 (also known as Keytruda) 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.

As a result, NICE has said that the results of the KEYNOTE-048 clinical trial, which grouped all forms of head and neck cancer together irrespective of their location and used the three-drug cocktail as the standard arm, do not provide enough evidence that the drug would offer a larger benefit than the current, ‘extreme’ form of chemotherapy.

It has asked the manufacturer of pembrolizumab, Merck & Co., Inc., which sponsored the KEYNOTE-048 led in the UK by the ICR and The Royal Marsden, to submit further evidence looking at oral cavity and other head and neck cancers separately.

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.”

The ICR – a charity and research institute – has less than £10 million left to raise of a £75 million investment in a new Centre for Cancer Drug Discovery, which will be focused on creating a new generation of ‘anti-evolution’ treatments.