Table 2.
The clinical trials when TMB as a biomarker.
| Trial | Phase | Treatment and target | Tumor type | TMB stratification | Testing method | Endpoint | References |
|---|---|---|---|---|---|---|---|
| NCT02915432 | Phase Ib/II, multi-center | Toripalimab, PD-1 | Advanced GC/ESCC | TMB-high ≥ 12 mut/Mb TMB-low <12 mut/Mb |
WES | mOS | (78) |
| KEYNOTE 061 (NCT02370498) |
Phase III, multi-center | Pembrolizumab, PD-1 | Advanced GC | TMB-high > 175 | MSK-IMPACT | – | (9) |
| NCT02870920 | Phase II, RCT | Durvalumab, PD-L1 | Recurrent CRC | TMB-high ≥ 28 mut/Mb TMB-low <28 mut/Mb |
F1CDx | mOS | (79) |
| REGONIVO (NCT03406871) |
Phase Ib, open-label | Nivolumab, PD-1 | Advanced GC/CRC | TMB-high ≥ 22.55 mut/Mb TMB-low <22.55 mut/Mb |
NR | mOS | (80) |
| Morris et al. (12) | – | ICIs | Multiple tumor types | CRC: TMB-high ≥ 52.2 mut/Mb EC: TMB-high ≥ 8.8 mut/Mb |
MSK-IMPACT | – | (12) |
RCT, randomized clinical trial; PD-1, programmed death-1; PD-L1, programmed death-ligand 1; GC, gastric cancer; EC, esophageal cancer; ESCC, esophageal squamous cell cancer; CRC, colorectal cancer; TMB, tumor mutational load; mOS, median overall survival; WES, whole-exome sequencing; MSK-IMPACT, Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets; F1CDx, FoundationOne CDx.