Table 2

Efficacy of pembrolizumab versus chemotherapy in the 3randomized clinical trials included in the analysis by TMB ≥175 mutations/exome and TMB <175 mutations/exome

StudyTMB ≥175 mutations/exomeTMB <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-0102.82 (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-0453.05 (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-0613.43 (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.