The Cancer Letter

The leading source for information on the issues that shape oncology since 1973

Issue 46 – Dec. 13, 2013

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One result, two reactions: GRAIL’s Hall and NCI’s Castle react to negative NHS-Galleri trial outcome

On Feb. 19, GRAIL Inc. announced that its pivotal NHS-Galleri trial failed to meet its primary endpoint of reduction in advanced stage cancers. The media and the market reacted as one would expect: GRAIL’s stock price halved the day after the announcement and at least three law firms said that they are conducting investigations in preparation for filing investor suits.
News Analysis

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

If you listen to GRAIL executives discuss the results of the long-awaited trial of the company’s multicancer detection test, you might be led to conclude that the company’s pivotal NHS-Galleri study had an overwhelmingly positive result.
By Jacquelyn Cobb and Sara Willa Ernst
Conversation with The Cancer Letter

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.
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.
By Jacquelyn Cobb and Sara Willa Ernst

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