Ontology highlight
ABSTRACT: Background
There is uncertainty around clinical applicability of tumor mutational burden (TMB) across cancer types, in part because of inconsistency between TMB measurements from different platforms. The KEYNOTE 158 trial supported United States Food and Drug Administration (FDA) approval of the Foundation Medicine test (FoundationOneCDx) at TMB≥10 mut/Mb as a companion diagnostic (CDx) for single-agent pembrolizumab in second+line. Using a large real-world dataset with validated survival endpoint data, we evaluated clinical validity of TMB measurement by the test in over 8000 patients across 24 cancer types who received single-agent immune checkpoint inhibitor (ICI).Methods
Patients with advanced-stage cancers from 24 cancer types treated with single-agent anti-PD(L)1 ther
SUBMITTER: Gandara DR
PROVIDER: S-EPMC11815411 | biostudies-literature | 2025 Feb
REPOSITORIES: biostudies-literature