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Table 3 Impact of patients’ and disease characteristics (combined variables) on treatment response and overall survival since the beginning of combined immunotherapy

From: Tumor mutation burden and circulating tumor DNA in combined CTLA-4 and PD-1 antibody therapy in metastatic melanoma – results of a prospective biomarker study

  Total n = 35 Responder n = 15 Non-Responder n = 20 Response P value Overall survival P value
Combination of TMB [Mut/Mb] and ctDNA [copies/ml] detection3
TMB > 23 Mut/Mb
+ ctDNA not detectable
3 3 0 < 0.0001 1* 0.005 2*
TMB > 23 Mut/Mb
+ ctDNA detectable
3 3 0
TMB ≤ 23 Mut/Mb
+ ctDNA not detectable
8 5 3
TMB ≤ 23 Mut/Mb
+ ctDNA detectable
13 0 13
Combination of TMB [Mut/Mb] and ctDNA [copies/ml] increase3
TMB > 23 Mut/Mb
+ ctDNA not increasing
4 4 0 < 0.0001 1* 0.032 2*
TMB > 23 Mut/Mb
+ ctDNA increasing
1 1 0
TMB ≤ 23 Mut/Mb
+ ctDNA not increasing
12 5 7
TMB ≤ 23 Mut/Mb
+ ctDNA increasing
9 0 9
Combination of TMB [Mut/Mb] and cell-free DNA [ng/ml]4
TMB > 23 Mut/Mb
+ cfDNA decrease > 50%
3 3 0 0.001 1* 0.016 2*
TMB > 23 Mut/Mb
+ cfDNA stable
1 1 0
TMB > 23 Mut/Mb
+ cfDNA increase > 50%
1 1 0
TMB ≤ 23 Mut/Mb
+ cfDNA decrease > 50%
3 1 2
TMB ≤ 23 Mut/Mb
+ cfDNA stable
11 4 7
TMB ≤ 23 Mut/Mb
+ cfDNA increase > 50%
7 0 7
Combination of TMB [Mut/Mb] and liver metastases
TMB > 23 Mut/Mb
+ no liver metastases
6 6 0 < 0.0001 1* 0.018 2*
TMB ≤ 23 Mut/Mb
+ no liver metastases
14 5 9
TMB ≤ 23 Mut/Mb
+ liver metastases
10 1 9
Combination of TMB [Mut/Mb] and sex
TMB > 23 Mut/Mb
+ male
6 6 0 0.002 1* 0.010 2*
TMB ≤ 23 Mut/Mb
+ female
9 2 7
TMB ≤ 23 Mut/Mb
+ female
15 4 11
  1. * significant (in bold).
  2. 1Exact Chi-Square Test for Trend (Monte Carlo Simulation)
  3. 2Log rank test for Trend
  4. 3ctDNA measured by tumor-specific variant [copies/ml plasma] at first follow-up after start of combined immunotherapy
  5. 4Cell-free DNA [ng/ml plasma] at first follow-up after start of combined immunotherapy