Table 2.
Study | TMB ≥175 mutations/exome | TMB <175 mutations/exome | ||||
ORR, OR (95% CI) |
PFS, HR (95% CI) |
OS, HR (95% CI) |
ORR, OR (95% CI) |
PFS, HR (95% CI) |
OS, HR (95% CI) |
|
KEYNOTE-010 | 2.82 (0.98 to 8.11) | 0.59 (0.40 to 0.87) | 0.56 (0.38 to 0.83) | 0.76 (0.29 to 2.00) | 1.09 (0.72 to 1.63) | 0.85 (0.56 to 1.30) |
KEYNOTE-045 | 3.05 (1.20 to 7.79) | 0.62 (0.40 to 0.96) | 0.63 (0.40 to 1.00) | 1.10 (0.55 to 2.21) | 1.13 (0.87 to 1.47) | 0.71 (0.54 to 0.94) |
KEYNOTE-061 | 3.43 (0.99 to 11.85) | 0.73 (0.44 to 1.22) | 0.46 (0.27 to 0.81) | 0.61 (0.31 to 1.22) | 1.78 (1.43 to 2.22) | 1.12 (0.90 to 1.41) |
ORR and PFS were assessed per RECIST V.1.1 by independent central review.
ORR, objective response rate; PFS, progression-free survival; TMB, tumor mutational burden.