Lumakras NSCLC - PFS Endpoint Unreliable in Confirmatory Study

Oncologic Drugs Advisory Committee Meeting

Voting on Supplemental new drug application (sNDA) Lumakras (sotorasib) tablets, submitted by Amgen Inc, for the treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C–mutated locally advanced or metastatic non–small cell lung cancer, as determined by an FDA-approved test, who have received ≥1 prior systemic therapy.

Vast majority of the Oncologic Drugs Advisory Committee (ODAC) agreed that the primary endpoint—progression-free survival (PFS) per blinded independent central review (BICR)—in CodeBreaK 200, the confirmatory study conducted by Amgen Inc to support full approval of Lumakras (IDRAC 363620) (sotorasib), could not be reliably interpreted.

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