Table 3.

Univariate and multivariate analysis of factors affecting outcome for patients with all tumor types excluding melanoma and NSCLC treated with immunotherapy agents (TMB low or intermediate vs. high; N = 63)a

VariableGroup (N)PR/CR N (%)OR (95% CI)bP univariate (PR/CR)cP multivariate (PR/CR)Median PFS (mos)dHR (95% CI) (PFS)bP univariate (PFS)eP multivariate (PFS)Median OS (mos)dHR (95% CI) (OS)bP-value univariate (OS)eP-value multivariate (OS)
Age≤60 years (n = 33)4 (12%)0.38 (0.12–1.35)0.20173.41.44 (0.82–2.54)0.203311.11.25 (0.60–2.65)0.5449
>60 years (n = 30)8 (27%)2.64 (0.74–8.55)2.70.69 (0.39–1.22)11.20.80 (0.39–1.66)
GenderMen (n = 41)11 (27%)7.7 (1.11–86.57)0.04330.2192.90.70 (0.38–1.29)0.212811.11.23 (0.56–2.69)0.6085
Women (n = 22)1 (5%)0.13 (0.01–0.90)3.51.43 (0.78–2.63)Not reached (median f/u of 5.4 mos)0.81 (0.37–1.77)
EthnicityCaucasian (n = 40)10 (25%)3.50 (0.77–17.00)0.18300.2543.60.64 (0.35–1.18)0.11790.49911.20.63 (0.29–1.38)0.2047
Hispanic (n = 7)0 (0%)0 (0–2.58)0.32921.91.38 (0.52–3.65)0.45153.12.82 (0.76–10.44)0.01680.053
Asian (n = 7)1 (14%)0.68 (0.05–5.40)1.00002.01.62 (0.57–4.56)0.2597Not reached (median f/u of 3.7 mos)1.15 (0.32–4.07)0.8179
African American (n = 6)1 (17%)0.70 (0.06–5.51)1.00005.01.047 (0.41–2.69)0.9212Not reached (median f/u of 6.0 mos)0.80 (0.22–2.97)0.7625
Other (n = 3)0 (0%)0 (0–4.99)1.00003.61.66 (0.38–7.21)0.3849Not reached (median f/u of 8.6 mos)0.72 (0.13–4.05)0.7491
TMBLow to intermediate (n = 46)4 (9%)0.11 (0.03–0.44)0.00160.0062.13.31 (1.86–5.91)0.00070.00311.11.88 (0.84–4.22)0.18470.362
High (n = 17)8 (47%)9.33 (2.28–31.23)10.00.30 (0.17–0.54)11.20.53 (0.24–1.20)
Type of immunotherapyAnti–PD-1/PD-L1 monotherapy (n = 55)9 (16%)0.33 (0.06–1.43)0.17000.1202.90.97 (0.38–2.48)0.947711.21.23 (0.46–3.28)0.6633
Other immunotherapy5 (n = 8)3 (38%)3.07 (0.70–15.99)2.61.03 (0.40–2.63)25.40.81 (0.31–2.17)
  • NOTE: Significant P values were bolded.

  • Abbreviations: CI, confidence interval; CR, complete response; PR, partial response.

  • aAll univariate P values of ≤0.2 were included in the multivariate analysis. For a similar analysis by TMB low versus intermediate to high, see Supplementary Table S5. For an analysis of melanoma and NSCLC on their own, see Supplementary Tables S20–S23. 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).

  • bOR >1.0 implies higher chance of response; HR <1.0 implies less chance of progression or death.

  • cCalculated using Fisher exact test.

  • dAll medians for PFS and OS calculated by Kaplan–Meier.

  • eCalculated using log-rank (Mantel–Cox) test.

  • fOther immunotherapy: OX40 (n = 2), anti-CD73 (n = 1), anti-CTLA4 (n = 2), OX40 + anti-PD-L1 (n = 1), anti-CTLA4/anti-PD-1/PD-L1 (n = 1), and IDO + anti-PD-1/PD-L1 (n = 1).