Table 2.
Clinical outcomes measures stratified according to tissue TMB status
| Study | ORR (TMB-high) n (%) | ORR (TMB-low) n (%) | PFS (TMB-high) HR (95% CI) | PFS (TMB-low) HR (95% CI) | OS (TMB-high) HR (95% CI) | OS (TMB-low) HR (95% CI) |
|---|---|---|---|---|---|---|
| KEYNOTE-04228 | 62/180 (34.4) versus 51/165 (30.9) | 44/234 (18.8) versus 48/214 (22.4) | 0.75 (0.59-0.95) | 1.27 (1.04-1.55) | 0.62 (0.48-0.80) | 1.09 (0.88-1.36) |
| CheckMate 227 part 131-210 | 63/139 (45.3) versus 43/160 (26.9) | N.A. | 0.58 (0.43-0.77) | 1.07 (0.84-1.35) | 0.68 (0.51-0.91) | 0.75 (0.59-0.94) |
| CheckMate 02613 | N.A. | N.A. | 0.62 (0.38-1.00) | 1.82 (1.30-2.55) | 1.1 (0.64-1.88) | 0.99 (0.71-1.4) |
| MYSTIC32 tissue D + T versus CT | N.A. | N.A. | 0.97 (0.63-1.49) | 1.98 (1.42-2.78) | 0.72 (0.48-1-09) | 1.39 (1.00-1.92) |
| MYSTIC32 tissue D versus CT | N.A. | N.A. | 0.86 (0.55-1.33) | 1.49 (1.95-2-13) | 0.70 (0.47-1.06) | 1.26 (0.90-1.77) |
| MYSTIC32 blood D + | 31/64 (48.4) versus 15/70 (21.4) | 34/204 (16.7) versus 58/185 (31.4) | 0.53 (0.34-0.81) | 1.55 (1.23-1.94) | 0.49 (0.32-0.74) | 1.16 (0.93-1.45) |
| MYSTIC32 blood D versus CT | 23/77 (29.9) versus 15/70 (21.4) | 43/209 (20.6) versus 58/185 (31.4) | 0.77 (0.52-1.13) | 1.19 (0.94-1.50) | 0.72 (0.50-1.05) | 0.93 (0.74-1.16) |
| IMpower11033 | N.A. | N.A. | 0.55 (0.33-0.92) | 1.00 (0.78-1.29) | 0.75 (0.41-1.35) | 1.07 (0.77-1.47) |
CI, confidence interval; CT, platinum-based chemotherapy; D, durvalumab; HR, hazard ratio; N.A., not available; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; T, tremelimumab; TMB, tumor mutational burden.