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Amgen Inc. said it would continue to work closely with the Food and Drug Administration to seek full approval for its Lumakras cancer drug as a treatment for a form of lung cancer, after an advisory panel found fault with a late-stage trial on Thursday.
The drug was granted approval in 2021 under an accelerated program that was conditional on further confirmatory trials. The panel gathered Thursday to review data from a Phase 3 trial dubbed CodeBreak 200 that evaluated Lumakras as a treatment for patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC).
The panel was asked to vote on whether the primary endpoint, progression-free survival (PFS) per blinded independent central review (BICR), could be reliably interpreted and voted 10 to 2 that it could not.
The FDA is not obliged to follow the panel’s recommendations but it often does.
“We will continue to progress our comprehensive global KRASG12C inhibitor development program exploring multiple LUMAKRAS combination regimens, including in colorectal cancer,” Amgen said in a statement. “We will continue to work closely with the FDA on the full approval pathway for this important medicine.”
The panel’s vote was based on its determination that the trial had “multiple sources of systemic bias,” according to documents that were published earlier this week.
Experts found that the trial allowed too many patients to switch between the control and treatment arms and that too many withdrew consent for the data to be relied on.
“The trial results are confounded by multiple sources of systemic bias, raising concerns about whether CodeBreaK 200 can be considered an adequate and well controlled trial,” said the documents. “Furthermore, the primary endpoint of PFS by BICR may not be reliable, given its magnitude relative to the imaging interval (5 weeks vs 6 weeks).”
Mizuho analysts said the fact that the purpose of the meeting was not to remove Kumakras from the market was a positive for future oncology trials.
“We see the potential for increased scrutiny of trials when the effect size is determined to be low, as seemed to be indicated by the FDA’s review,” wrote analyst Mara Goldstein in a note to clients.
“Over the past two years the FDA has increased the demand for confirmatory trials –in the context of Accelerated Approval — and it does not appear that this will lessen in the near term, but we see oncology valuations already reflecting that.”
Amgen said that to date, over 15,000 patients worldwide have received Lumakras.
The stock was flat premarket and has gained 0.3% in the year to date, while the SPDR S&P Biotech ETF
XBI
has fallen 13% S&P 500
SPX
has gained 11%.
