Table 3.
Overall and subgroup analysis of best objective response to salvage nivolumab plus ipilimumab (n = 230). Objective response rate assessment used tumor measurements at salvage nivolumab plus ipilimumab initiation as baseline.
| No. of patients | No. (%) of confirmed CR/PR | P-value | |
|---|---|---|---|
| All subjects | 230 | 29 (12.6%) | |
| Prior treatment status | |||
| Treatment naïve | 127 | 015 (11.8%) | .69 |
| Previously treated | 103 | 014 (13.6%) | |
| IMDC risk groups | |||
| Favorable | 35 | 005 (14.3%) | .37 |
| Intermediate | 158 | 022 (13.9%) | |
| Poor | 37 | 002 (5.4%) | |
| Response to nivolumab at ipilimumab start | |||
| SD | 62 | 005 (8.1%) | .21 |
| PD | 168 | 024 (14.3%) | |
| Best ORR to nivolumab monotherapy | |||
| CR | 3 | 002 (66.7%) | NR |
| PR | 21 | 004 (19.0%) | |
| SD | 86 | 007 (8.1%) | |
| PD | 120 | 016 (13.3%) | |
| Best ORR to nivolumab monotherapy | |||
| Response (confirmed CR/PR) | 24 | 006 (25.0%) | .09 |
| Non-response | 206 | 023 (11.2%) | |
| Initiation of ipilimumab within 18 weeks | |||
| No | 57 | 008 (14.0%) | .71 |
| Yes | 173 | 021 (12.1%) | |
| Initiation of ipilimumab within 24 weeks | |||
| No | 42 | 006 (14.3%) | .72 |
| Yes | 188 | 023 (12.2%) | |
Abbreviations: CR: complete response; PR: partial response; IMDC: International Metastatic RCC Database Consortium; SD: stable disease; PD: progressive disease; ORR: objective response rate; NR: not reported.