OnCo
trialsTrialCompleted

NHS-Galleri

The largest cancer screening trial ever run, testing whether a multi-cancer blood test reduces late-stage diagnoses.

Primary endpoint: reduction in stage III-IV cancer incidence. Interim 2024 results did not trigger early NHS rollout. Final results presented at ASCO 2026: the primary endpoint (stage III-IV reduction) was not met, while stage IV incidence fell by about 14%; the data feed the FDA PMA and the September 2026 advisory committee. See the ASCO 2026 digest for sources.

Setting
140,000 asymptomatic adults aged 50-77 randomised to annual Galleri testing or control for 3 years
Phase
Phase 3
Sponsor
NHS England / GRAIL
Enrolled
142000
Replication
The only randomised MCED trial; PATHFINDER 2 (single-arm) is consistent on detection rate and PPV. Mortality benefit remains untested.

Outcomes

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In plain words
What these results mean for people, not percentages
142,000 people took part
Stage III–IV incidence, 12 prespecified cancers (primary)primaryother endpoint
  • Numbers are not recorded here for this endpoint. Galleri + standard screening: Not met: no statistically significant reduction within one year of the last screen; a fall in stage IV was offset by a rise in stage III.; Standard screening.
Relative reduction in stage IV diagnoses, rounds 2 and 3other endpoint
  • 22 vs 26 out of 100 reached this endpoint with Round 2 compared with Round 3; 4 fewer per 100.
  • On this measure the first group did worse, not better.
Relative reduction in diagnosis through emergency presentationother endpoint
  • 25 out of 100 people reached this endpoint with Galleri + standard screening.
  • There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
Be careful
  • This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
  • These results apply to the people the trial enrolled: 140,000 asymptomatic adults aged 50-77 randomised to annual Galleri testing or control for 3 years. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

142,000 participants enrolled.

Stage III–IV incidence, 12 prespecified cancers (primary)primary

Not met: no statistically significant reduction within one year of the last screen; a fall in stage IV was offset by a rise in stage III.

Source
Relative reduction in stage IV diagnoses, rounds 2 and 3
Round 222 of 100
Round 326 of 100

Relative reduction versus control in the 12 prespecified cancers

Source
Relative reduction in diagnosis through emergency presentation
Galleri + standard screening25 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Stage III–IV incidence, 12 prespecified cancers (primary)primaryGalleri + standard screeningNot met: no statistically significant reduction within one year of the last screen; a fall in stage IV was offset by a rise in stage III.link
Standard screening
Relative reduction in stage IV diagnoses, rounds 2 and 3Round 222%link
Round 326%
Relative reduction in diagnosis through emergency presentationGalleri + standard screening25%link
Replication
The only randomised MCED trial; PATHFINDER 2 (single-arm) is consistent on detection rate and PPV. Mortality benefit remains untested.

Key papers

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Connected

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