Amgen’s disappointing Lumakras data at ESMO could shake up KRAS race

Results of the Phase III confirmatory study of Amgen’s Lumakras are seeding doubts that the KRAS inhibitor’s accelerated approval will convert to a full approval this year — a decision that will have a major impact on Amgen’s share of the KRAS inhibitor market in the face of advancing competition.

The data may mean Amgen Inc. (NASDAQ:AMGN) won’t be able to shut the door on its closest competitor  Mirati Therapeutics Inc. (NASDAQ:MRTX), which has a December PDUFA date for its KRAS G12C inhibitor adagrasib in the same indication, previously treated non-small cell lung cancer (NSCLC). If Amgen’s accelerated approval is converted to a full approval before a decision is reached on adagrasib, Mirati’s therapy will no longer be eligible for accelerated approval in NSCLC. ...