BOR, ORR, and DOR by treatment arm and tTMB-H or bTMB-H status 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) | |
| BOR—no (%) | ||||
| CR | 13 (14.8) | 3 (6.4) | 4 (5.0) | 2 (4.4) |
| PR | 21 (23.9) | 11 (23.4) | 14 (17.5) | 5 (11.1) |
| SD | 13 (14.8) | 4 (8.5) | 8 (10.0) | 6 (13.3) |
| PD | 30 (34.1) | 21 (44.7) | 41 (51.3) | 20 (44.4) |
| Non-CR/PD | 1 (1.1) | 0 | 1 (1.3) | 1 (2.2) |
| UTD | 10 (11.4) | 8 (17.0) | 12 (15.0) | 11 (24.4) |
| ORR—(%), 95% CI | 34 (38.6) 28.4–49.6 | 14 (29.8) 17.3–44.9 | 18 (22.5) 13.9–33.2 | 7 (15.6) 6.5–29.5 |
| DOR—months | ||||
| Median (95% CI) | NA | NA | NA (10.2 to NA) | NA (5.5 to NA) |
| Range | 5.4–33.9+ | 5.0–31.4+ | 5.4–33.9+ | 5.5–30.6+ |
| Events—no/no (%) | 6/34 (17.6) | 4/14 (28.6) | 5/18 (27.8) | 1/7 (14.3) |
| Patients with DOR of at least: | ||||
| 9 months—% (95% CI) | 90 (73 to 97) | 78 (46 to 92) | 83 (55 to 94) | 86 (33 to 98) |
| 12 months—% (95% CI) | 78 (57 to 90) | 70 (38 to 88) | 76 (47 to 90) | 86 (33 to 98) |
*201 patients were in the primary analysis population; 82 patients had both tTMB-H and bTMB-H.
BOR, best overall response; bTMB-H, high blood tumor mutational burden; CR, complete response; DOR, duration of response; IPI, ipilimumab; NA, not available; NIVO, nivolumab; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease; tTMB-H, high tissue tumor mutational burden; UTD, unable to determine.