US FDA panel says Amgen lung cancer drug data cannot be relied on

[October 06, 2023]  By Bhanvi Satija and Pratik Jain

(Reuters) -Advisers to the U.S. Food and Drug Administration on Thursday found that data from a late-stage trial of Amgen's Lumakras could not be relied on, raising questions about the agency's upcoming decision on whether to grant traditional approval of the drug for a type of advanced lung cancer.

The drug was approved by the FDA in 2021 under an accelerated pathway, with confirmatory data a condition for gaining traditional approval.

The main goal of the confirmatory study was progression-free survival (PFS), or how long before the disease begins to worsen, but the FDA questioned some methods used in conducting the trial.

An FDA spokesperson said the agency cannot comment on its next steps but it intends to keep the drug available for patients for now.

"It is under accelerated approval and there are multiple pathways available to us. We are not making this move to withdraw the drug from the market," said Harpreet Singh of the FDA oncology division.

The FDA's expert advisers voted 10 to 2 that the main goal of the late-stage confirmatory study could not be relied upon to assess the benefits of the drug, although several panel members noted that the voting question was very narrowly framed.

Much of the committee's discussion centered on concerns that trial investigators allowed too many patients to switch between the treatment and control arms of the study.

Data from the confirmatory study showed that Lumakras reduced the risk of disease progression in patients with advanced lung cancer by 34% compared with chemotherapy.

Lumakras showed no significant difference in overall survival - the gold standard for cancer drugs - but Amgen said the study was not designed to demonstrate a survival benefit.

An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013. The biopharmaceutical company reports earnings on Tuesday. REUTERS/Robert Galbraith/File Photo

The panel's decision was in line with an assessment from FDA staff reviewers, who suggested earlier this week that the trial data may be biased and may not be sufficient to confirm the benefits of Lumakras.

They flagged several issues with the trial, including the way the study was conducted and loss of follow-up data from patients who withdrew consent.

Lumakras is approved to treat advanced lung cancer in patients with mutations of the KRAS gene whose disease has worsened after chemotherapy or other treatments.

The FDA grants accelerated approval where there is an unmet need and data demonstrating a drug is likely to work. It requires confirmatory trials be conducted to prove safety and efficacy in order to receive traditional approval.

Lumakras is an oral drug designed to target a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common type of lung cancer, and less frequently in some other solid tumors.

The FDA, which generally follows the advice of its expert panels but is not bound to do so, is expected to make a decision on the traditional approval for Amgen's drug by Dec. 24.

(Reporting by Pratik Jain and Bhanvi Satija in Begaluru and Deena Beasley in Los Angeles; Editing by Bill Berkrot)

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