FDA staff voice concerns about whether Amgen’s CodeBreaK 200 trial ‘adequate’

Background information prepared by the Food and Drug Administration staff for the panel members of the Oncologic Drugs Advisory Committee Meeting being called on October 5 to review the sotorasib new drug application made by Amgen states in part: “CodeBreaK 200 was a trial designed to verify the clinical benefit of single agent sotorasib vs docetaxel, after the initial accelerated approval of sotorasib based on single arm data yielding an ORR of 36%. However, the trial results are confounded by multiple sources of systemic bias, raising concerns about whether CodeBreaK 200 can be considered an adequate and wellcontrolled trial. Furthermore, the primary endpoint of PFS by BICR may not be reliable, given its magnitude relative to the imaging interval.”