An update on the ongoing NHS-Galleri trial

Based on data from the first year of the three-year NHS-Galleri trial, NHS England has decided that it will wait to see final results, expected in 2026, before considering whether an NHS rollout of the Galleri multi cancer early detection test (the Multi Cancer Blood Test Programme, MCBT) should go ahead.

NHS England’s commercial agreement with health technology company GRAIL in November 2020 positioned the NHS at the forefront of an exciting area of healthcare innovation, and the company’s Galleri® test is now being subjected to one of the most rigorous investigations in any healthcare system worldwide. Over 140,000 people between the ages of 50 and 77 years have taken part in what is the world’s largest prospective trial of a multi cancer early detection blood test.

Using a blood sample taken from a patient, the Galleri test works by detecting a common signal among more than 50 cancer types, meaning that a cancer could be detected earlier – even before a patient experiences any symptoms.

The NHS-Galleri trial was designed with three consecutive years of screening, and it is vital to evaluate the primary objective and endpoints at the end of the study in 2026. The primary endpoint of the trial is an absolute reduction in the number of late stage (stage 3 and 4) cancers diagnosed, and cancer-specific mortality will also be analysed after five years of follow up.

Many successful cancer screening trials have failed to show a stage shift initially, and it is frequently observed that the first-year data will differ from the final trial results.

NHS England has reviewed preliminary data from the first year of the NHS-Galleri trial and did not find them compelling enough to justify proceeding straight away with a large-scale pilot programme of the test in NHS clinical practice, while we await the final results of the trial. Committing to accelerate implementation of the test in the NHS at scale would have been an exceptional step, requiring exceptional data after just one year, and while what we have seen is very promising, the data so far do not support moving at such a fast pace.

It’s important to note that the preliminary data is not an early assessment of the trial’s primary endpoint. The first year data showed a high level of accuracy for the test, and we hope to see more evidence of test performance, earlier stage at diagnosis and improved outcomes once the trial has been completed.

Multi cancer early detection blood tests, like Galleri, are an exciting area of innovation that could become a key component of the NHS ambition to improve cancer diagnosis, and in doing so, help more people survive cancer.

Successful completion of the ongoing clinical trial remains critical to informing future decisions and, as planned, those taking part in the trial will continue to have appointments into July 2024. It is vital that these final appointments and any resulting diagnostic investigations are completed to ensure a comprehensive picture can be reached about the potential future benefits of the test.

As planned at the outset of the trial, the results will be used by the UK National Screening Committee to consider whether the Galleri test could play a role in a national cancer screening programme. We think that NHS patients should be the first to benefit from new technologies, and we want to be ready to make the test available to an increasing number of people rapidly if the final trial results show evidence of significant benefit for patients.

Even as the Galleri test remains under active investigation in the trial, the NHS in England will continue to deliver a wide range of initiatives for the early detection, diagnosis, and treatment to improve cancer care and outcomes as set out in the NHS England Long Term Plan. Recent highlights include:

  • The NHS exceeding its faster diagnosis cancer target in early 2024, amid record demand. Thanks to the hard work of NHS staff, nearly eight in 10 people received a definitive cancer diagnosis or the all clear within four weeks.
  • In March 2024, we marked a milestone of 100,000 patients benefitting from faster access to cancer treatments through the Cancer Drugs Fund since July 2016.
  • The NHS seeing over 3 million patients for vital cancer checks in a 12-month period for the first time in history: this is more than twice as many checks as were carried out a decade ago.
Peter Johnson

Professor Peter Johnson is Professor of Medical Oncology at the University of Southampton. He was Chief Clinician for Cancer Research UK for ten years where he established pilot work in genomic analysis for cancer patients. He co-chaired the CRUK/Royal College of GPs Cancer Clinical Priority Group. He is currently Chair of the Royal College of Physicians/Association of Cancer Physicians joint specialty committee on medical oncology. He was appointed CBE for services to cancer research in 2016.