Amgen fails in bid for full FDA approval of KRAS inhibitorKRAS inhibitor Lumakras

26 Dec 2023
firstwordpharma.com
Phase 3Clinical ResultDrug ApprovalAccelerated Approval
The FDA rebuffed Amgen’s attempt to gain full approval of Lumakras (sotorasib), with the agency asking the company to conduct a new confirmatory study for the KRAS inhibitor. The decision - detailed in a complete response letter - had been expected after a recent negative advisory panel vote on the application.
Lumakras gained accelerated FDA approval in 2021 for patients with KRASG12c-mutated non-small-cell lung cancer (NSCLC) who had received at least one prior systemic therapy. The decision was based on objective response rate data from the CodeBreaK 100 study, with Amgen later submitting results of the Phase III CodeBreaK 200 to support the drug's conversion to traditional approval.
While CodeBreaK 200 met its primary endpoint with a significant 34% progression-free survival (PFS) benefit for Lumakras versus docetaxel, an FDA advisory panel voted 10 to 2 that the data could not be reliably interpreted. Ahead of the vote, agency staff released briefing documents saying that survival data from the trial were "uncertain," and that the study may not be considered "adequate and well-controlled."
Larger study size
Amgen said Tuesday that the new confirmatory study must be completed no later than February 2028, although it did not reveal further details. However, speaking at the recent advisory panel meeting, committee chair Ravi Madan highlighted the small size of the CodeBreaK 200 trial, which enrolled 345 patients.
The next key catalyst in the KRAS inhibitorKRAS inhibitor space is likely to be PFS and interim overall survival data from the confirmatory KRYSTAL-12 study of Mirati Therapeutics’ Krazati (adagrasib) in the first half of 2024. The drug has accelerated approval in the US for the second-line treatment of adults with KRAS G12C-mutated locally advanced or metastatic NSCLC.
Despite the promise around KRAS inhibitorsKRAS inhibitors, sales of Lumakras have failed to take off as expected, with revenue from the product falling quarter-over-quarter in Amgen’s most recent financial results. For a deeper look, read Vital Signs: Do KRAS blunders weigh down targeted therapy in lung cancer?
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