Table 1

Summary of studies evaluating blood TMB as a predictive biomarker for response to immune checkpoint blockade

StudyAnalysisApproachNGS assayPanel sizeCohort sizeTumor typeDisease stageTrial IDTreatmentTMB cut-off
Khagi et al, 2017145RetrospectiveTargeted NGSGuardant 360 (73 genes)200 Kbn=69Pan-cancerNot reportedN/AAnti-PD1/PDL1/CTLA4VUS,
>3 alterations
Gandara et al, 201860RetrospectiveTargeted NGSCustom NGS assay (bait set version T7, Integrated DNA Technology, >300 genes)1.1 Mbn=259NSCLCAdvanced/metastaticPOPLAR (NCT01903993); OAK (NCT02008227)Atezolizumab vs docetaxel16 Mutations/Mb
Wang et al, 2019146RetrospectiveTargeted NGSCustom assay (NCC-GP150, 150 genes)Not reportedn=48 cohort 1; n=50 cohort 2NSCLCAdvanced/metastaticN/AAnti-PD-1/PD-L16 Mutations/Mb
Si et al, 202163RetrospectiveTargeted NGSGuardant OMNI (500 genes)2 Mbn=1001NSCLCMetastaticMYSTIC (NCT02453282)Durvalumab and tremelimumab vs chemotherapy20 Mutations/Mb
de Castro Jr et al, 202265ProspectiveTargeted NGSGuardant OMNI (500 genes)2 Mbn=512NSCLCMetastaticNEPTUNE (NCT02542293)Durvalumab and tremelimumab versus chemotherapy20 Mutations/Mb
Kim et al, 202266ProspectiveTargeted NGSFoundation Medicine (>300 genes)1.1 Mbn=152NSCLCLocally advanced/metastaticB-F1RST (NCT02848651)Atezolizumab16 Mutations/Mb
Peters et al, 202268ProspectiveTargeted NGSFoundation Medicine (>300 genes)1.1 Mbn=472NSCLCAdvanced/metastaticBFAST (NCT03178552)Atezolizumab versus chemotherapy16 Mutations/Mb
He et al, 202269; Schenker et al, 202270ProspectiveTargeted NGSFoundation Medicine (>300 genes)1.1 Mbn=212Pan-cancerAdvanced/metastaticCheckMate 848 (NCT03668119)Nivolumab+ipilimumab vs nivolumab monotherapy10 Mutations/Mb
  • BFAST, Blood First Assay Screening Trial; bTMB, blood tumor mutation burden; N/A, not available; NGS, next-generation sequencing; NSCLC, Non-small cell lung cancer; VUS, variants of unknown significance.