In top-line results released alongside full-year financial figures, Grail said the NHS-Galleri study failed to demonstrate a statistically significant reduction in the combined incidence of stage III and stage IV cancers among participants who received the Galleri test compared with those who did not.
Despite missing the main endpoint, Grail reported additional findings from the trial. The company stated that there was “a favorable trend toward fewer stage III-IV cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round.”
The specified group included cancers of the anus, bladder, colorectal region, esophagus, head and neck, liver and bile duct, lung, lymphoma, myeloma or plasma cell neoplasm, ovary, pancreas and stomach. A detailed dataset has not yet been released and is expected to be presented at this year’s meeting of the American Society of Clinical Oncology.
The three-year study was conducted within England’s National Health Service and enrolled more than 142,000 individuals aged 50 to 77. It evaluated annual multicancer screening using Galleri in addition to standard-of-care screening.
According to the company, adding Galleri to routine screening led to a reduction in stage IV diagnoses compared with standard screening alone across the pre-specified group of 12 cancers. Stage IV diagnoses in these cancers declined with each year of repeated screening, with reductions exceeding 20% in the second and third screening rounds. Similar decreases were observed across all cancer types included in the analysis.
The intervention arm also showed an increase in the absolute number of stage I and stage II cancers detected within the 12 cancer types, which are typically identified at later stages.
Based on the current findings, Grail said it intends to extend the trial’s follow-up period by six to 12 months to evaluate whether a stronger effect emerges as the data continue to mature.
The NHS study plays a central role in the company’s regulatory strategy. Grail recently submitted a premarket approval application to the U.S. Food and Drug Administration for Galleri. The application includes data from a U.S. study involving about 25,000 participants as well as first-year results from the NHS-Galleri trial. The larger NHS trial was designed to assess whether the test could lower late-stage cancer diagnoses and increase early detection rates to inform a potential screening program in England.
Grail Chief Executive Officer Bob Ragusa said the company would be “expanding field-based sales and medical teams to bolster our education efforts and support growing demand.”
The company also reported full-year revenue of $147.2 million, representing a 17% increase compared with the prior year. U.S. Galleri revenue rose 26% year over year to $136.8 million.
Separately, Canaccord Genuity analyst Kyle Mikson stated that while FDA approval of Galleri does not appear to be at material risk, it remains uncertain whether the Centers for Medicare and Medicaid Services will factor the NHS data into future coverage determinations. Earlier this month, U.S. President Donald Trump signed legislation permitting Medicare coverage of multi-cancer early detection tests for older adults beginning in 2028, depending on age.
Galleri Trial Misses Primary Endpoint in NHS Study
The much-anticipated Galleri blood test has encountered a setback after Grail announced that the large NHS-Galleri trial failed to meet its primary endpoint. The outcome marks a significant moment for Galleri, which has been positioned as a groundbreaking multi-cancer early detection test.
The NHS-Galleri trial, conducted in partnership with the National Health Service, aimed to evaluate whether Galleri could significantly reduce late-stage cancer diagnoses through earlier detection in asymptomatic individuals.
Grail’s large-scale NHS study evaluating its multi-cancer early detection blood test has delivered mixed results after failing to meet the trial’s primary endpoint. The study, conducted in partnership with the National Health Service, was designed to determine whether the test could significantly reduce the number of late-stage cancer diagnoses in a broad screening population.
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