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.