GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”
Mainstream epidemiologists beg to differ

Undeterred by the negative topline result of its pivotal trial of Galleri, a multicancer detection test, the test’s sponsor, GRAIL, said it’s forging ahead with its plan to get FDA approval and reimbursement from CMS and private insurers.

March 06, 2026

Vol.52 No.09

By Jacquelyn Cobb and Sara Willa Ernst

Conversation with The Cancer Letter

NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”
Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs

Philip E. Castle, director of the NCI Division of Cancer Prevention, said he was disappointed to hear that GRAIL’s NHS-Galleri trial did not meet its primary endpoint of reduction in late-stage cancers.

March 06, 2026

Vol.52 No.09

By Jacquelyn Cobb and Sara Willa Ernst

Clinical Roundup

NHS-Galleri MCD trial fails to meet primary endpoint of stage shift

High-level results from the randomized, controlled NHS-Galleri trial, which is evaluating GRAIL’s multi-cancer screening test, Galleri, over three years in 142,000 participants aged 50 to 77, reveals that the trial did not meet its primary endpoint of shifting cancer diagnosis from advanced stages (3 and 4) to earlier stage (1 and 2).

Super Bowl ad by Hims & Hers features GRAIL’s Galleri MCD test

A Super Bowl LX commercial by Hims & Hers, a controversial direct-to-consumer medication platform, featured the company’s new offering: Galleri, a multi-cancer detection test produced by GRAIL Inc.

February 13, 2026

Vol.52 No.06

By Jacquelyn Cobb and Sara Willa Ernst

Clinical

Class action complaint alleging GRAIL insider fraud resubmitted after dismissal

Following last month’s dismissal of the securities class action complaint against Illumina Inc. and its former spinoff company, GRAIL, the plaintiffs have refiled an amended complaint, keeping the action alive.

Early endpoints are a balance of risk and benefit

Early endpoints have the potential to get effective drugs to patients faster, but granting approval to drugs—even accelerated approval—comes with the risk that ineffective or even harmful drugs will be given to patients.

October 29, 2025

Vol.51 No.39

GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study

Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

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GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”
Mainstream epidemiologists beg to differ

NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”
Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs

NHS-Galleri MCD trial fails to meet primary endpoint of stage shift

Super Bowl ad by Hims & Hers features GRAIL’s Galleri MCD test

Class action complaint alleging GRAIL insider fraud resubmitted after dismissal

Early endpoints are a balance of risk and benefit

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GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study

Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

YOU MAY BE INTERESTED IN

GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”Mainstream epidemiologists beg to differ

NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs

NHS-Galleri MCD trial fails to meet primary endpoint of stage shift

Super Bowl ad by Hims & Hers features GRAIL’s Galleri MCD test

Class action complaint alleging GRAIL insider fraud resubmitted after dismissal

Early endpoints are a balance of risk and benefit

Never miss an issue!

Login

GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”
Mainstream epidemiologists beg to differ

NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”
Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs