Table 2.
Objective Response and Durability of Response
| Outcomesa | Total Cohort | Arm A (NIVO + IPI) | Arm B (NIVO + IPI + SBRT) | |||
|---|---|---|---|---|---|---|
| ICI Naïve (N=24) |
Prior ICI (N=26) |
ICI Naïve (N=13) |
Prior ICI (N=12) |
ICI Naïve (N=11) |
Prior ICI (N=14) |
|
| ORR [95%CI] | 100 [82-100] | 31 [15-52] | 100 [72-100] | 42 [16-71] | 100 [63-100] | 21 [6-51] |
| BOR, No. (%) | ||||||
| Complete Response | 9 (41) | 4 (15) | 7 (54) | 3 (25) | 2 (22) | 1 (7) |
| Partial Response | 13 (59) | 4 (15) | 6 (46) | 2 (17) | 7 (78) | 2 (14) |
| Stable Disease | 0 (0) | 1 (4) | 0 (0) | 1 (8) | 0 (0) | 0 (0) |
| Progressive Disease | 0 (0) | 17 (65) | 0 (0) | 6 (50) | 0 (0) | 11 (79) |
| Nonevaluableb | 2 | 0 | 0 | 0 | 2 | 0 |
| Progression following initial response, No. (%) | 2 (9) | 4 (50) | 2 (15) | 3 (60) | 0 (0) | 1 (33) |
| Median DOR, mo [95%CI]c | NE [34-NE] | 11 [5-NE] | NE [34-NE] | 15 [7-NE] | NE | 5 [3-NE] |
a
Numbers were rounded to the nearest whole number.
b
Two patients deemed nonevaluable as the target lesion was irradiated.
c
Includes 30 responders with at least 6 months of follow-up.
Abbreviations: BOR, best overall response; 95%CI, 95% confidence interval, ICI, immune-checkpoint inhibitor; NIVO, nivolumab; IPI, ipilimumab; ORR, objective response rate; SBRT, stereotactic body radiation therapy, DOR, duration of response, NE, non-estimable.