Table 2.
Summary of clinical trials that have evaluated different TMB cut-offs for predicting the response to immunotherapy.
| Trial | Treatment arms | Cut-off (mutation per megabase) | No. of patients | OS | PFS | ||
|---|---|---|---|---|---|---|---|
| Median | HR | Median | HR | ||||
| CheckMate 026 (6) | NIVO vs CTH | High TMB | 107 | 18.3 | 1.1 | 9.7 | 0.62 |
| Low or medium | 195 | 12.7 | 0.99 | 4.1 | 1.82 | ||
| CheckMate 227 (7) | NIVO + IPI vs CTH | TMB ≥ 10 | 199 | 7.2 | 0.58 | ||
| TMB < 10 | 380 | 3.2 | 1.07 | ||||
| OAK (14) | ATEZO vs. CTH | TMB ≥ 10 | 251 | 0.69 | 0.73 | ||
| TMB ≥ 16 | 158 | 0.64 | 0.65 | ||||
| TMB ≥ 20 | 105 | 0.65 | 0.61 | ||||
| POPLAR (13) | ATEZO vs. CTH | TMB ≥ 10 | 96 | 0.59 | 0.67 | ||
| TMB ≥ 16 | 63 | 0.56 | 0.57 | ||||
| TMB ≥ 20 | 42 | 0.51 | 0.58 | ||||
| B-F1RST (16) | ATEZO | bTMB ≥ 12 | 22 | 3 | 0.95 | ||
| bTMB < 12 | 36 | 3.2 | |||||
| bTMB ≥ 14 | 14 | 3.4 | 0.73 | ||||
| bTMB < 14 | 44 | 3.2 | |||||
| bTMB ≥ 16 | 14 | 9.5 | 0.49 | ||||
| bTMB < 16 | 47 | 2.8 | |||||
| bTMB ≥ 20 | 8 | 9.5 | 0.23 | ||||
| bTMB < 20 | 50 | 2.7 | |||||
ATEZO, atezolizumab; CTH, chemotherapy; HR, hazard ratio; IPI, ipilimumab; NIVO, nivolumab; OS, overall survival; PFS, progression-free survival; TMB, tumor mutational burden; bTMB, blood based TMB.