Table 1.
Confirmed objective response per independent radiology review committee in intermediate-risk/poor-risk patients, the ITT population, and in favorable-risk patients
| Response assessment | IMDC intermediate risk/poor risk |
ITT population | IMDC favorable risk | |||
| NIVO+IPI (N=425) |
SUN (N=422) |
NIVO+IPI (N=550) |
SUN (N=546) |
NIVO+IPI (N=125) |
SUN (N=124) |
|
| Objective response rate, % (95% CI) | 42.1 (37.4–47.0) | 26.3 (22.2–30.8) | 39.1 (35.0–43.3) | 32.6 (28.7–36.7) | 28.8 (21.1–37.6) | 54.0 (44.9–63.0) |
| p<0.0001 | p=0.0190 | p<0.0001 | ||||
| Best overall response, % | ||||||
| Complete response | 10.1 | 1.4 | 10.7 | 2.4 | 12.8 | 5.6 |
| Partial response | 32.0 | 24.9 | 28.4 | 30.2 | 16.0 | 48.4 |
| Stable disease | 30.6 | 44.3 | 35.8 | 41.6 | 53.6 | 32.3 |
| Progressive disease | 19.8 | 17.3 | 18.2 | 14.5 | 12.8 | 4.8 |
| Unable to determine/not reported | 7.5 | 12.1 | 6.9 | 11.4 | 4.8 | 8.9 |
| Median time to response (IQR), months |
N=179
2.8 (2.7–3.3) |
N=111
3.6 (2.8–5.6) |
N=215
2.8 (2.7–4.0) |
N=178
4.0 (2.8–5.8) |
N=36
2.8 (2.7–4.3) |
N=67
4.2 (2.8–7.2) |
| Ongoing response, n (%) | 121 (67.6) | 58 (52.3) | 146 (67.9) | 94 (52.8) | 25 (69.4) | 36 (53.7) |
| Ongoing response in complete responders, n (%) |
N=43
36 (83.7) |
N=6
6 (100.0) |
N=59
51 (86.4) |
N=13
12 (92.3) |
N=16
15 (93.8) |
N=7
6 (85.7) |
| Ongoing response in partial responders, n (%) |
N=136
85 (62.5) |
N=105
52 (49.5) |
N=156
95 (60.9) |
N=165
82 (49.7) |
N=20
10 (50.0) |
N=60
30 (50.0) |
IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; IQR, interquartile range; ITT, intention-to-treat; NIVO+IPI, nivolumab plus ipilimumab; SUN, sunitinib.