Patient demographics and baseline characteristics in the primary analysis population
| tTMB-H (n=135)* | bTMB-H (n=125)* | |||
| NIVO+IPI (n=88) | NIVO (n=47) | NIVO+IPI (n=80) | NIVO (n=45) | |
| Age—years | ||||
| Mean (SD) | 59.8 (11.2) | 57.2 (13.6) | 59.5 (11.7) | 56.6 (10.7) |
| Median (range) | 61.5 (33–81) | 58 (22–82) | 61 (30–79) | 58 (37–74) |
| Sex—no (%) | ||||
| Male | 39 (44.3) | 23 (48.9) | 39 (48.8) | 17 (37.8) |
| Female | 49 (55.7) | 24 (51.1) | 41 (51.3) | 28 (62.2) |
| Region—no (%) | ||||
| Europe | 54 (61.4) | 33 (70.2) | 51 (63.8) | 34 (75.6) |
| North America | 5 (5.7) | 1 (2.1) | 9 (11.3) | 1 (2.2) |
| Rest of the world | 29 (32.9) | 13 (27.6) | 20 (25.1) | 10 (22.2) |
| Patients with prior systemic therapy—no (%) | 83 (94.3) | 45 (95.7) | 80 (100) | 44 (97.8) |
| Number of prior systemic regimens—no (%) | ||||
| 1 | 36 (40.9) | 18 (38.3) | 22 (27.5) | 15 (33.3) |
| 2 | 17 (19.3) | 8 (17.0) | 25 (31.3) | 8 (17.8) |
| 3 | 8 (9.1) | 10 (21.3) | 9 (11.3) | 9 (20.0) |
| ≥4 | 22 (25.0) | 9 (19.1) | 24 (30.0) | 12 (26.7) |
| Median (range) | 2.0 (0–10) | 2.0 (0–8) | 2.0 (1–9) | 2.0 (0–7) |
*201 patients were in the primary analysis population; 82 patients had both tTMB-H and bTMB-H, and the bTMB-H population was randomized before December 20, 2019.
bTMB-H, high blood tumor mutational burden; IPI, ipilimumab; NIVO, nivolumab; tTMB-H, high tissue tumor mutational burden.