Table 2. Statistical Summary of the Association of TMB With Clinical Outcomes.
Cohort | Model | End point | TMB, HR | 1-Sided UCB | P value |
---|---|---|---|---|---|
All evaluable | Univariate | OS | 0.72 | 0.91 | .01 |
Prospective | Univariate | OS | 0.61 | 0.84 | .005 |
Prospective | Univariate | PFS | 0.62 | 0.82 | .003 |
Prospective | Univariate | TTP | 0.67 | 0.92 | .02 |
Prospective pembrolizumab treated | Univariate | OS | 0.67 | 0.94 | .03 |
Prospective nonpembrolizumab treated | Univariate | OS | 0.37 | 0.85 | .03 |
Prospective | Multivariablea | OS | 0.67 | 0.92 | .02 |
Abbreviations: OS, overall survival; PFS, progression-free survival; TMB, tumor mutational burden; TTP, time to progression; UCB, upper confidence bound.
In the multivariable model, the variables tested for association with OS are TMB, programmed cell death-ligand 1 status (positive/negative/unknown) and microsatellite instability status (high vs low).