Variable | Group | Number for all patients N = 151 (%) | TMB low to intermediate n = 113 (%) | TMB high n = 38 (%) | P^{b} |
---|---|---|---|---|---|

Age | <60 years | 78 (52%) | 67 (59%) | 11 (29%) | 0.0014 |

≥60 years | 73 (48%) | 46 (41%) | 27 (71%) | ||

Sex | Men | 93 (62%) | 64 (56%) | 29 (76%) | 0.0349 |

Women | 58 (38%) | 49 (44%) | 9 (24%) | ||

Ethnicity | Caucasian | 111 (74%) | 77 (68%) | 34 (89%) | 0.0104 |

Hispanic | 18 (12%) | 18 (16%) | 0 (0%) | 0.0070 | |

Asian | 9 (6%) | 7 (6%) | 2 (5%) | 1.0000 | |

African American | 9 (6%) | 8 (7%) | 1 (3%) | 0.4505 | |

Other | 4 (3%) | 3 (3%) | 1 (3%) | 1.0000 | |

Tumor type | Melanoma | 52 (34%) | 34 (30%) | 18 (47%) | 0.0748 |

NSCLC^{c} | 36 (24%) | 33 (29%) | 3 (8%) | 0.0077 | |

Other tumors^{d} | 63 (42%) | 46 (41%) | 17 (45%) | 0.7060 | |

Type of immunotherapy | Anti-PD-1/PD-L1 alone | 102 (68%) | 80 (71%) | 22 (58%) | 0.1631 |

Anti-CTLA4 alone | 15 (10%) | 10 (9%) | 5 (13%) | 0.5308 | |

High-dose IL2 | 9 (6%) | 7 (6%) | 2 (5%) | 1.0000 | |

Anti-CTLA4/Anti-PD-1/PD-L1 | 17 (11%) | 11 (10%) | 6 (16%) | 0.3732 | |

Other immunotherapy^{e} | 8 (5%) | 5 (3%) | 3 (8%) | 0.4157 | |

Response | CR/PR | 45 (30%) | 23 (20%) | 22 (58%) | 0.0001 (OR 5.38; 95% CI, 2.44–11.58)^{f} |

SD or PD | 106 (70%) | 90 (80%) | 16 (42%) | 0.0001 (OR 0.19; 95% CI, 0.09–0.41)^{f} | |

PFS | Median (months) | 4.6 | 3.3 (2.98) | 12.8 (0.34) | <0.0001 (HR 0.34; 95% CI, 0.23–0.50)^{f} |

OS | Median (months) | 25.4 | 16.3 (3.03) | Not reached (median f/u of 10.5 mos) | 0.0036 (HR 0.33, 95% CI, 0.19–0.58)^{f} |

NOTE: Significant

*P*values were bolded.Abbreviations: CI, confidence interval; CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease.

↵

^{a}See Supplementary Table S2 for patient demographics by TMB low versus intermediate to high.↵

^{b}Calculated using Fisher exact test and log-rank (Mantel–Cox) test where appropriate.↵

^{c}Histologies included the following: adenocarcinoma (*N*= 30) and squamous cell carcinoma (*N*= 6).↵

^{d}Tumors included the following: adrenal carcinoma (*n*= 1), appendix adenocarcinoma (*n*= 1), basal cell carcinoma (*n*= 2), bladder transitional cell carcinoma (*n*= 4), breast cancer (*n*= 3), cervical cancer (*n*= 2), colon adenocarcinoma (*n*= 5), cutaneous squamous cell carcinoma (*n*= 8), hepatocellular carcinoma (*n*= 3), head and neck (*n*= 13), Merkel cell carcinoma (*n*= 2), ovarian carcinoma (*n*= 2), pleural mesothelioma (*n*= 1), prostate cancer (*n*= 1), renal cell carcinoma (*n*= 6), sarcoma (*n*= 3), thyroid cancer (*n*= 3), unknown primary squamous cell carcinoma (*n*= 2), and urethral squamous cell carcinoma (*n*= 1).↵

^{e}Other immunotherapy: OX40 (*n*= 3), anti-CD73 (*n*= 1), Talimogene laherparepvec (*n*= 2), OX40 + anti-PD-L1 (*n*= 1), and IDO + anti-PD-1 (*n*= 1).↵

^{f}OR >1.0 implies higher chance of response; HR <1.0 implies less chance of progression or death; OR and HR refer to TMB high versus TMB low to intermediate.