Table 2. Publications reporting primary efficacy outcomes (OS, PFS, ORR) in patients receiving active therapy for lung cancer.
| Median OS (Months) [HR (95% CI)/P Value] | Median PFS (Months) [HR (95% CI)/P Value] | ORR (%) [P Value] | |
|---|---|---|---|
| IMMUNOTHERAPY | |||
| Carbone 2017 [10] | |||
| Nivolumab/1L | Low/intermediate vs high TMB: 12.7 vs 18.3 [P: NR] | Low vs intermediate vs high TMB: 6.9 vs 6.5 vs 9.7 [P: NR] | Low/intermediate vs high TMB: 23% vs 47% [P: NR] |
| Davis 2017 [28] | |||
| PD-1/PD-L1 inhibitors | Longer with high TMB [0.19 (0.04 to 0.88); P = .034] | NR | NR |
| Gettinger 2017 [29] | |||
| PD-1/PD-L1 inhibitors | NR [P = .92] | NR | Higher with high TMB [P = .02] |
| Goodman 2017 [16] | |||
| PD-1/PD-L1 inhibitors | Low/intermediate vs high TMB: 7.6 vs not reached [0.32 (0.07 to 1.50); P = .15] | Low/intermediate vs high TMB: 2.1 vs 12.5 [0.32 (0.13 to 0.81); P = .0817] | Low/intermediate vs high TMB: 18% vs 33% [P = .4882] |
| Kowanetz 2017 [30] | |||
| Atezolizumab/1L | Longer with high TMB [50th percentile: 0.79 (0.39 to 1.58), P: NR; 75th percentile: 0.45 (0.17 to 1.16), P: NR] | Longer with high TMB [50th percentile: 0.58 (0.36 to 0.94), P: NR; 75th percentile: 0.54 (0.3 to 0.97), P: NR] | Low vs high TMB (50th percentile): 13% vs 28% [P: NR] Low vs high TMB (75th percentile): 20% vs 25% [P: NR] |
| Atezolizumab/2L | Longer with high TMB [50th percentile: 0.87 (0.65 to 1.16), P: NR; 75th percentile: 0.7 (0.49 to 1.0), P: NR] | Longer with high TMB [50th percentile: 0.64 (0.5 to 0.8), P: NR; 75th percentile: 0.5 (0.38 to 0.67), P: NR] | Low vs high TMB (50th percentile): 14% vs 25% [P: NR] Low vs high TMB (75th percentile): 16% vs 29% [P: NR] |
| Haratani 2017 [31] | |||
| Nivolumab | NR | NR | Higher with high TMB [P = .038] |
| Hellmann 2017 [34] | |||
| Anti-PD-L1 +/- anti-CTLA-4 therapy | NR | Longer with high TMB [HR: 0.59 (95% CI: NR); P = .004] | NR |
| Hellmann 2018 [33] | |||
| Nivolumab + Ipilimumab | NR | Low vs high TMB: 3.2 vs 7.2 [P: NR] | NR |
| Hellmann 2018 [32] | |||
| Nivolumab | Low/intermediate vs high TMB: 3.1 vs 5.4 [P: NR] | Low/intermediate vs high TMB: 1.3 vs 1.4 [P: NR] | Low/intermediate vs high TMB: 7% vs 21% [P: NR] |
| Nivolumab + ipilimumab | Intermediate vs high TMB: 3.4 vs 22.0 [P: NR] | Low/intermediate vs high TMB: 1.3 vs 7.8 [P: NR] | Low/intermediate vs high TMB: 22% vs 46% [P: NR] |
| Mahadevan 2017 [36] | |||
| PD-1/PD-L1 inhibitors | NR | Longer with high TMB [P = . 015] | NR |
| Park 2017 [37] | |||
| Nivolumab | Low vs intermediate vs high TMB: 12.4 vs 10.3 vs not reached [P = .211] | NR | NR |
| Patel 2017 [38] | |||
| Immunotherapy | NR [P = .5] | NR | NR |
| Rizvi 2015 [1] | |||
| Pembrolizumab (cohort 1) | NR | Low/intermediate vs high TMB: 3.7 vs 14.5 [P = .01] | Low vs high TMB: 0% vs 63% [P = .03] |
| Pembrolizumab (cohort 2) | NR | Low/intermediate vs high TMB: 3.4 vs not reached [P = .006] | Low vs high TMB: 22% vs 56% [NR] |
| Roszik 2016 [39] | |||
| Pembrolizumab | NR | Low vs high TMB: 4.1 vs 8.3 [P = .0003] | Low vs high TMB: 0% vs 48% [NR] |
| Singal 2017 [41] | |||
| Nivolumab | Low/intermediate vs high TMB: 10 vs not reached [P < .01] | NR | NR |
| Yaghmour 2016 [44] | |||
| Nivolumab, pembrolizumab, or ipilimumab | Low vs high TMB: 4.9 vs not reached [HR undefined (95% CI: 0.04 to 1.90); P = .21] | NR | NR |
| CHEMOTHERAPY | |||
| Carbone 2017 [10] | |||
| Platinum-based chemotherapy | NR | Low vs intermediate vs high TMB: 4.2 vs 3.6 vs 5.8 [NR] | Low/intermediate vs high TMB: 33% vs 28% [NR] |
| Hellmann 2018 [33] | |||
| Chemotherapy | NR | Low vs high TMB: 5.5 vs 5.5 [NR] | NR |
| NOT SPECIFIED | |||
| Choi 2017 [27] | |||
| Not specified | NR [P = .5933] | NR [P = .7765] | NR |
| Wang 2017* [42] | |||
| Not specified | NR | Shorter with high TMB* [P = .0133] | NR |
| Xiao 2016 [43] | |||
| Not specified | Low vs high TMB: 61 vs 48.4 [P = .02] | NR | NR |
Abbreviations: CI, confidence interval; HR, hazard ration; NR, not reported; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TMB, tumor mutational burden.
*Wang 2017 presents disease-free survival, not progression-free survival.