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Table 2 Tumor Mutation Burden as Predictor of Non-small Cell Lung Cancer Outcome: OS and PFS Data

From: Targeted literature review on use of tumor mutational burden status and programmed cell death ligand 1 expression to predict outcomes of checkpoint inhibitor treatment

Trial/Author (Year)Subpopulation or PopulationTreatmentNo. of PatientsOSPFS
Median (95% CI), MonthsHR(95% CI)Median (95% CI), MonthsHR(95% CI)
CheckMate 026
Carbone et al. (2017) [17]
Socinski et al. (2016) [18]
High TMBNIVO 3 mg/kg Q2W4718.3 (11.4-NE)1.1 (0.64–1.88)9.7 (5.1-NE)0.62 (0.38–1.0)
Platinum-based chemotherapy Q3W6018.8 (11.3-NE)5.8 (4.2–8.5)
Low or medium TMLNIVO 3 mg/kg Q2W11112.7 (9.9–16.1)0.99 (0.71–1.4)4.1 (2.8–5.4)1.82 (1.3–2.55)
Platinum-based chemotherapy Q3W9413.2 (9.5–15.2)6.9 (5.5–8.6)
CheckMate 227
Hellmann et al. (2018) [4]
TMB ≥ 10 mutations per mbNIVO + IPI139NRNR7.2 (5.5–13.2)0.58 (97.5% CI, 0.41–0.81)
Chemotherapy160NRNR5.5 (4.4–5.8)
TMB < 10 mutations per mbNIVO + IPI191NRNR3.2 (2.7–4.3)1.07 (0.84–1.35)
Chemotherapy189NRNR5.5 (4.3–5.6)
OAKa
Rittmeyer et al. (2017) [6]
Gadgeel et al. (2017) [19]
Barlesi et al. (2016) [20]
Hida et al. (2018) [21]
Gandara et al. (2017) [22]
TMB ≥ 10ATEZO vs. DTX251NR0.69 (NR)NR0.73 (NR)
TMB ≥ 16 158NR0.64 (NR)NR0.65 (NR)
TMB ≥ 20105NR0.65 (NR)NR0.61 (NR)
POPLARa
Fehrenbacher et al. (2016) [23]
Smith et al. (2016) [24]
Mazieres et al. (2016) [25]
Vansteenkiste et al. (2015) [26]
Spira et al. (2015) [27]
Gandara et al. (2017) [22]
TMB ≥ 10ATEZO vs. DTX96NR0.59 (NR)NR0.68 (NR)
TMB ≥ 1663NR0.56 (NR)NR0.57 (NR)
TMB ≥ 2042NR0.51 (NR)NR0.58 (NR)
Yaghmour (2016)
[28]
TML: top quintile≥ First line, NIVO or IPI50 (overall patients)NR3.29 (0.75–25.53)NRNR
TML: other quintilesNRNRNR
B-F1RST
Velcheti (2018) [29]
Blood-based TMB ≥ 12ATEZO22NRNR30.95 (90% CI, 0.55–1.63)
Blood-based TMB < 1236NRNR3.2
Blood-based TMB ≥ 1414NRNR3.40.73 (90% CI, 0.39–1.39)
Blood-based TMB < 1444NRNR3.2
Blood-based TMB ≥ 1611NRNR9.50.49 (90% CI, 0.23–1.04)
Blood-based TMB < 1647NRNR2.8
Blood-based TMB ≥ 208NRNR9.50.23 (90% CI, 0.08–0.62)
Blood-based TMB < 2050NRNR2.7
  1. ATEZO atezolizumab; CI confidence interval; DTX docetaxel; HR hazard ratio; IPI ipilimumab; mb megabase; NE could not be estimated/not reached; NIVO nivolumab; NR not reported; OS overall survival; PFS progression-free survival; Q2W every 2 weeks; Q3W every 3 weeks; TMB tumor mutational burden; TML tumor mutational load
  2. aBlood based TMB