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ISSUE 43 – NOV. 15, 2013PDF

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“Master Protocol” To Rely on Biomarkers In Testing Multiple Lung Cancer Agents

A new kind of clinical trial that will assign patients to therapy based on molecular characteristics of their disease is being launched by a coalition of government agencies, pharmaceutical companies, and a non-government organization.

The effort, called the lung cancer “Master Protocol,” is a phase II and phase III trial that would test five drugs, assigning patients to therapy based on tumor biomarkers.

photoVarmus: “We Are Shrinking Everything” To Keep Grant Numbers Level During Cuts

As NCI digs out after the two-week shutdown of the federal government, its leadership has to contend with the prospect of another shutdown weeks away, which may kick in after the current continuing resolution expires Jan. 15, 2014.

photoFDA Grants Accelerated Approval to Imbruvica

FDA granted an accelerated approval to Imbruvica (ibrutinib) for mantle cell lymphoma patients who have received at least one prior therapy.

Imbruvica was approved four months after submission of its New Drug Application. The agent is sponsored by Pharmacyclics Inc.

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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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