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Table 5 TMB predicts the efficacy of ICB therapy

From: Mismatch repair deficiency/microsatellite instability-high as a predictor for anti-PD-1/PD-L1 immunotherapy efficacy

Clinical trial

Phase

Drug

TMB (mut/Mb)

Tumor

N

Response

PFS

OS

CheckMate026 [88]

III

Nivolumab

H ≥ 243

NSCLC

47

ORR 47%

*mPFS, 9.7 moths

1-year OS, 64%; mOS, 18.3 months

Platinum-based CT

60

ORR 28%

*mPFS, 5.8 months

1-year OS, 60%; mOS, 18.8 months

Nivolumab

L 0 to 99 and M 100 to 242

111

ORR 23%

mPFS, 4.1 months

1-year OS, 54%; mOS, 12.7 months

Platinum-based CT

94

ORR 33%

mPFS, 6.9 months

1-year OS, 53%; mOS, 13.2 months

CheckMate568 [89]

II

Nivolumab + ipilimumab

< 5,

5–10,

10–15,

≥ 15

NSCLC

288

ORR 4%, ORR 10%, ORR 44%, ORR 39%

NA

NA

CheckMate227 [90]

III

Nivolumab + ipilimumab

≥ 10

NSCLC

139

ORR 45.3%

1-year DoR 68%

*1-year PFS, 42.6%

*mPFS, 7.2 months

NA

Platinum doublet CT

160

ORR 26.9%

1-year DoR 25%

*1-year PFS, 13.2%

*mPFS, 5.5 months

Nivolumab + ipilimumab

< 10

   

mPFS, 3.2 months

 

Platinum doublet CT

    

mPFS, 5.5 months

 

CheckMate 032 [91]

Exploratory

Nivolumab + ipilimumab

H ≥ 248

SCLC

26

ORR 46.2%

1-year PFS, 30.3%

mPFS, 7.8 months

1-year OS, 62.4%; mOS, 22.0 months

Nivolumab

47

ORR 21.3%

1-year PFS, 21.2%

mPFS, 1.4 months

1-year OS, 35.2%; mOS, 5.4 months

Nivolumab + ipilimumab

M 143 to 247

25

ORR 16.0%

1-year PFS, 8.0%

mPFS, 1.3 months

1-year OS, 19.6%; mOS, 3.6 months

Nivolumab

44

ORR 6.8%

1-year PFS, 3.1%

mPFS, 1.3 months

1-year OS, 26.0%; mOS, 3.9 months

Nivolumab + ipilimumab

L 0 to 143

27

ORR 22.2%

1-year PFS, 6.2%; mPFS, 1.5 months

1-year OS, 23.4%; mOS, 3.4 months

Nivolumab

42

ORR 4.8%

1-year PFS, NC;mPFS, 1.3 months

1-year OS, 2.1%; mOS, 3.1 months

POPlAR [92]

Training

Atezolizumab

H-bTMB ≥ 16

NSCLC

25

NA

*mPFS, 4.2 months

*mOS, 13.0 months

Docetaxel

38

*mPFS, 2.9 months

*mOS, 7.4 months

OAK [92]

Validation

Atezolizumab

H-bTMB ≥ 16

NSCLC

77

ORR 21%

*PFS (HR 0.65, 95% CI 0.47–0.92; P = 0.013)

*mOS, 13.5 months

Docetaxel

81

ORR 10%

*mOS, 6.8 months

Atezolizumab

bTMB < 16

NSCLC

216

ORR 13%

PFS (HR 0.98, 95% CI 0.80–1.2)

OS (HR 0.65, 95% CI 0.52–0.81)

Docetaxel

  

209

ORR 12%

Zhijie W et al. [96]

 

Anti-PD-1/PD-L1 therapies

bTMB ≥ 6

bTMB < 6

NSCLC

28

22

*ORR 39.3%

*ORR 9.1%

*mPFS: NR

*mPFS, 2.9 months

 
  1. Abbreviations: N number, ICBs immune checkpoint blockades, PD-L1 programmed death ligand 1, PD-1 programmed death-1, CTLA-4 cytotoxic T lymphocyte antigen-4, mAb monoclonal antibody, NSCLC non-small cell lung cancer, SCLC small-cell lung cancer, CT chemotherapy, ORR objective response rate, DoR duration of response, PFS progression-free survival, mPFS median progression-free survival, OS overall survival, mOS median overall survival, TMB tumor mutation burden, H high, M medium, L low, bTMB blood-based tumor mutation burden, mut mutation, mut/Mb mutation per megabase, Ref reference, vs versus, NR not reached, NA not available
  2. *Denotes the difference was statistically significant
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Journal of Hematology & Oncology

ISSN: 1756-8722

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