Image: Space-filling model of immunotherapy pembrolizumab
The Institute of Cancer Research, London, has welcomed the approval by the Scottish Medicines Consortium (SMC) of the immunotherapy, pembrolizumab, as a first-line NHS treatment for some patients with head and neck cancer.
Experts expect pembrolizumab to now completely replace the standard of care for the majority of NHS patients in Scotland – who are currently treated with chemotherapy.
But the ICR is concerned that the lack of a similar approval elsewhere in England, Wales or Northern Ireland could herald a ‘home nations lottery’ over cancer treatment.
Pembrolizumab will be made available on the NHS in Scotland for patients with head and neck cancer that has come back or spread, whose tumours have an immune marker called PD-L1.
The ICR’s experts are particularly welcoming of the SMC’s decision to approve pembrolizumab both on its own and in combination with platinum chemotherapy – as clinical trial evidence has shown there are important differences in outcome depending on the levels of the PD-L1 immune marker.
Practice-changing clinical trial
The ICR with its partner hospital The Royal Marsden NHS Foundation Trust led the UK arm of a practice-changing global clinical trial of pembrolizumab in recurrent head and neck cancer.
The trial, KEYNOTE-048, found pembrolizumab on its own or used with chemotherapy extended the lives of patients whose tumours are positive for PD-L1, compared with standard treatment – an ‘extreme’ combination of chemotherapy plus the targeted drug, cetuximab. The same ‘extreme’ regimen is the standard of care in England and Wales for patients whose tumour started in the oral cavity, with those whose cancer started outside the oral cavity treated with a two-drug chemotherapy combination.
As a result of the trial findings, US, European and Japanese regulators have approved both pembrolizumab alone and combined with chemotherapy, using slightly different criteria based on the PD-L1 level in the tumour.
The SMC’s recommendation matches the drug’s authorisation from the EMA, and with around 85 per cent of patients having a positive score for PD-L1, the majority of people in Scotland with head and neck cancer that has come back or spread now stand to benefit from pembrolizumab immunotherapy.
This is in contrast with England and Wales, where NICE earlier this year decided not to recommend pembrolizumab partly due to the historic decision to treat patients differently if their cancer started inside or outside the oral cavity – a distinction not made in the rest of the world.
NICE has extended access to pembrolizumab under NHS England guidance during the COVID-19 pandemic until April 2021, but after that access is due to end.
The Institute of Cancer Research works to influence policy development in high-priority areas and to give the ICR a voice on relevant policy issues.
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'Far better, kinder treatment for head and neck cancer'
Professor Kevin Harrington helped design the trial and led the UK arm of the KEYNOTE-048 trial looking at the benefit of pembrolizumab as a first-line treatment for relapsed or metastatic head and neck cancer.
Professor Harrington, Professor of Biological Cancer Therapies at the ICR, said:
“It’s fantastic news for patients that pembrolizumab, either on its own or with chemotherapy, will now be available on the NHS in Scotland as a first-line treatment option for people whose head and neck cancer has come back or spread.
“The SMC’s decision opens up two brand new standards of care for most patients in Scotland which can dramatically extend overall survival from less than a year with chemotherapy to three years or more with pembrolizumab for many patients.
“It’s clear that pembrolizumab is a far better, kinder treatment for head and neck cancer than the current standard of care. To prevent a home nations lottery in accessing the best available treatment for head and neck cancer that has come back or spread, I would urge NICE and the drug’s manufacturers to work together to come to an agreement to ensure patients in England and Wales can also benefit.”