Amgen Inc fails to secure US-FDA expert advisers support for Lumakras approval

The US FDA’s Oncologic Drugs Advisory Committee concluded that the data from a late-stage clinical trial data lacks the requisite reliability to endorse the traditional approval of Amgen Inc's Lumakras for patients afflicted with an advanced form of lung cancer.The US FDA's expert advisers voted 10-2, expressing doubts about relying on the primary goal of the late-stage confirmatory study to assess the drug's benefits. The panel of experts finds that Amgen’s progression-free survival data from the phase III confirmatory CodeBreaK 200 study could not be reliably interpreted. In particular, the adcomm noted the high number of study dropouts, the small sample size and potentially biased behavior of the trial’s investigators.   “No one expects a perfect randomized controlled trial but what we hope for is a small number of issues in trial conduct and an effect large enough to withstand the uncertainties caused by those issues,” committee member Mark Conaway, professor at the Division of Translational Research and Applied Statistics at the University of Virginia School of Medicine, said during Thursday’s meeting in explaining his vote against Amgen.   “For this trial, we seem to have the opposite - a large number of issues that cloud the interpretation of a small observed effect,” Conaway said. At the same time, some panelists pointed out that the question posed to the committee is not one that directly addresses Lumakras’ clinical efficacy, but instead narrowly focuses on the reliability of Amgen’s progression-free survival data for Lumakras.   Amgen is seeking full approval for Lumakras, which was authorized in May 2021 under the US FDA’s accelerated pathway. In a briefing document posted ahead of the adcomm meeting, the company provided data from CodeBreaK 200, which showed that Lumakras met its primary endpoint leading to a statistically significant reduction in the risk of disease progression or death compared with docetaxel.   However, US FDA staff in their briefing document for the adcomm meeting raised concerns of “systemic bias” in CodeBreaK 200. They contend that there was a much higher rate of study dropouts in the docetaxel comparator group in comparison to the Lumakras study arm, which the US FDA detected as “one of the first indications of possible systemic bias” in the study.   The agency also flagged the early crossover from the docetaxel to Lumakras arms - even before disease progression had been assessed - as well as investigator assessments that might have favored the investigational intervention.

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