Table 4.
Overall and subgroup analysis of progression-free survival after initiation of ipilimumab. Available only for OMNIVORE and HCRN 16-260 (n = 92).
| No. of patients | No. of events | 6 months PFS % (95% CI) |
Log-rank P-value |
|
|---|---|---|---|---|
| All patients | 92 | 77 | 37 (27-47) | |
| Prior treatment status | ||||
| Treatment naïve | 60 | 49 | 38 (25-51) | .56 |
| Previously treated | 32 | 28 | 35 (19-52) | |
| IMDC risk groups | ||||
| Favorable | 28 | 20 | 40 (20-59) | .048 |
| Intermediate | 57 | 50 | 37 (24-49) | |
| Poor | 7 | 7 | 29 (4-61) | |
| Objective response to nivolumab at ipilimumab start | ||||
| SD | 23 | 17 | 68 (44-83) | .008 |
| PD | 69 | 60 | 27 (17-38) | |
| Initiation of ipilimumab within 18 weeks | ||||
| No | 29 | 26 | 32 (16-49) | .96 |
| Yes | 63 | 51 | 40 (27-52) | |
| Initiation of ipilimumab within 24 weeks | ||||
| No | 20 | 18 | 32 (13-52) | .95 |
| Yes | 72 | 59 | 39 (27-50) | |
| Timing of ipilimimab start and objective response (to nivolumab) at ipilimumab start | ||||
| >24weeks, PD | 20 | 18 | 32 (13-52) | NR |
| <24weeks, SD | 23 | 17 | 68 (44-83) | |
| <24weeks, PD | 49 | 42 | 25 (13-38) | |
| Combination of best ORR and ORR at ipilimumab start | ||||
| SD only | 23 | 17 | 68 (44-83) | NR |
| SD to PD | 14 | 11 | 33 (10-59) | |
| CR/PR to PD | 8 | 8 | 25 (4-56) | |
| PD only | 47 | 41 | 25 (14-39) | |
Abbreviations: PFS: progression-free survival; CI: confidence interval; IMDC: International Metastatic RCC Database Consortium; SD: stable disease; PD: progressive disease; CR: complete response; PR: partial response; NR: not reported.