Table 2.
Summary of responses per RECIST V.1.1 and overall survival for all treated patients
| Nivolumab (n=18) |
Nivolumab plus ipilimumab (n=21) |
Nivolumab plus ipilimumab plus cobimetinib (n=30) |
||
| Investigator assessment | Investigator assessment | Investigator assessment | BICR assessment | |
| Objective response rate,* n/N (%) | 0/18 (0) | 0/21 (0) | 2/30 (6.7) | 3/30 (10.0) |
| 95% CI | 0.0 to 18.5 | 0.0 to 16.1 | 0.8 to 22.1 | 2.1 to 26.5 |
| Best overall response, n (%) | ||||
| Complete response | 0 | 0 | 0 | 0 |
| Partial response | 0 | 0 | 2 (7) | 3 (10) |
| Stable disease | 5 (28) | 7 (33) | 15 (50) | 15 (50) |
| Progressive disease | 9 (50) | 12 (57) | 9 (30) | 10 (33) |
| Unable to determine | 4 (22) | 2 (10) | 4 (13) | 2 (7) |
| Death before disease assessment | 3 (17) | 1 (5) | 2 (7) | 0 |
| Early discontinuation due to toxicity | 0 | 0 | 1 (3) | 0 |
| Other | 1 (6) | 1 (5) | 1 (3) | 0 |
| Median time to response‡ (range), months | 0 | 0 | 3.5 (2.5–4.4) | 1.4 (1.3–2.7) |
| Median duration of response‡ (95% CI), months | 0 | 0 | NE (3.3–NE) | NE (5.1–NE) |
| PFS | ||||
| Events, n (%) | 18 (100) | 19 (90) | 25 (83) | 23 (77) |
| Median (months) (95% CI) | 1.4 (1.3 to 2.0) | 1.4 (1.2 to 2.7) | 3.0 (1.5 to 4.1) | 3.1 (1.5 to 4.7) |
| PFS rate, % (95% CI) | ||||
| 3 months | 22 (7 to 43) | 19 (5 to 40) | 44 (26 to 62) | 52 (33 to 68) |
| 6 months | 6 (<1 to 22) | 6 (<1 to 25) | 17 (6 to 34) | 23 (9 to 41) |
| OS | ||||
| Events, n (%) | 18 (100) | 21 (100) | 22 (73) | – |
| Median (months) (95% CI) | 5.1 (2.0 to 9.0) | 4.0 (1.9 to 5.6) | 6.2 (3.9 to 11.4) | – |
| OS rate, % (95% CI) | ||||
| 3 months | 61 (35 to 79) | 62 (38 to 79) | 83 (65 to 93) | – |
| 6 months | 50 (26 to 70) | 24 (9 to 43) | 53 (33 to 69) | – |
| 12 months | 17 (4 to 37) | 10 (2 to 26) | 28 (13 to 45) | – |
*Evaluated in all treated patients.
†Percentages may not add up to 100% due to rounding.
‡Evaluated in patients who had an objective response.
BICR, blinded independent central review; NE, not estimable; OS, overall survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.