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. Author manuscript; available in PMC: 2022 Sep 14.
Published in final edited form as: Eur J Cancer. 2020 Apr 9;131:40–50. doi: 10.1016/j.ejca.2020.02.038

Table 1.

Evidence of TMB as a biomarker in clinical trial.

Tumour type Testing drug TMB method TMB cutoff Type of benefit
NSCLC Checkmate 026 Nivolumab WES >243 mut/exome ORR, PFS
Rozenblum et al, 2017 Nivolumab or pembrolizumab FoundationOne >9,6 mut/Mb ORR
KEYNOTE 001 Pembrolizumab WES >178 mut/exome ORR, PFS
POPLAR/OAK Atezolizumab Foundation bTMB >10 mut/Mb PFS, OS
POPLAR/FIR/BIRCH Atezolizumab FoundationOne 1st line: >13,5 mut/Mb
2nd line: >17,1 mut/Mb
ORR, PFS, OS
BFAST and BF1RST Atezolizumab Foundation bTMB Unknown ORR, PFS, OS
MSKCC, Rizvi et al, 2018 Multiagent (alone or in combination) WES >8,5 mut/Mb ORR, PFS
Checkmate 227 Ipilimumab + nivolumab FoundationOne >10 mut/Mb ORR, PFS
Checkmate 568 Ipilimumab + nivolumab FoundationOne >10 mut/Mb ORR, PFS
Checkmate 012 Ipilimumab + nivolumab WES >158 mut/exome ORR, PFS and clinical benefit
Melanoma Checkmate 064 Nivolumab WES Unknown ORR, OS
Van Allen et al 2015 Ipilimumab WES 197 mut/exome Clinical benefit
Snyder et al 2014 Ipilimumab WES >100 mut/exome OS
Johnson et al, 2016 Multiagent (alone or in combination) FoundationOne >23,1 mut/Mb ORR, PFS, OS
Hugo et al, 2016 Multiagent (alone or combination) WES >495 mut/exome OS
Checkmate 038 Nivolumab WES >100 mut/exome OS
Bladder Checkmate 275 Nivolumab WES >167 mut/exome ORR, PFS, OS
Imvigor 210 Atezolizumab FoundationOne >16 mut/Mb ORR, OS
Imvigor 211 Atezolizumab FoundationOne > median OS
Snyder et al, 2017 Atezolizumab WES > median PFS
SCLC Hellman et al, 2018 Nivolumab + ipilimumab WES >248 mut/exome ORR, PFS, OS
CRC KEYNOTE 012 - 028 Pembrolizumab WES Unknown ORR, PFS
Multiple solid tumours Goodman et al, 2017 Multiagent (alone or combination) FoundationOne >20 mut/Mb ORR, PFS, OS
Yarchoan et al, 2017 Multiagent (alone or combination) Various Various ORR