Table 1.

Patient demographics by TMB low or intermediate versus high (N = 151)a

VariableGroupNumber for all patients N = 151 (%)TMB low to intermediate n = 113 (%)TMB high n = 38 (%)Pb
Age<60 years78 (52%)67 (59%)11 (29%)0.0014
≥60 years73 (48%)46 (41%)27 (71%)
SexMen93 (62%)64 (56%)29 (76%)0.0349
Women58 (38%)49 (44%)9 (24%)
EthnicityCaucasian111 (74%)77 (68%)34 (89%)0.0104
Hispanic18 (12%)18 (16%)0 (0%)0.0070
Asian9 (6%)7 (6%)2 (5%)1.0000
African American9 (6%)8 (7%)1 (3%)0.4505
Other4 (3%)3 (3%)1 (3%)1.0000
Tumor typeMelanoma52 (34%)34 (30%)18 (47%)0.0748
NSCLCc36 (24%)33 (29%)3 (8%)0.0077
Other tumorsd63 (42%)46 (41%)17 (45%)0.7060
Type of immunotherapyAnti-PD-1/PD-L1 alone102 (68%)80 (71%)22 (58%)0.1631
Anti-CTLA4 alone15 (10%)10 (9%)5 (13%)0.5308
High-dose IL29 (6%)7 (6%)2 (5%)1.0000
Anti-CTLA4/Anti-PD-1/PD-L117 (11%)11 (10%)6 (16%)0.3732
Other immunotherapye8 (5%)5 (3%)3 (8%)0.4157
ResponseCR/PR45 (30%)23 (20%)22 (58%)0.0001 (OR 5.38; 95% CI, 2.44–11.58)f
SD or PD106 (70%)90 (80%)16 (42%)0.0001 (OR 0.19; 95% CI, 0.09–0.41)f
PFSMedian (months)4.63.3 (2.98)12.8 (0.34)<0.0001 (HR 0.34; 95% CI, 0.23–0.50)f
OSMedian (months)25.416.3 (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.

  • aSee Supplementary Table S2 for patient demographics by TMB low versus intermediate to high.

  • bCalculated using Fisher exact test and log-rank (Mantel–Cox) test where appropriate.

  • cHistologies included the following: adenocarcinoma (N = 30) and squamous cell carcinoma (N = 6).

  • dTumors 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).

  • eOther 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).

  • fOR >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.