Table 1 –
Select baseline characteristics of patients without prior nephrectomy and with an evaluable primary tumor and the intent-to-treat population
| Characteristic a | Patients without prior nephrectomy and with an evaluable primary tumor | Intent-to-treat patients [6] | ||
|---|---|---|---|---|
| NIVO + IPI (N = 53) | SUN (N = 55) | NIVO + IPI (N = 550) | SUN (N = 546) | |
| Median age, yr (range) | 64 (40–84) | 64 (34–85) | 62 (26–85) | 62 (21–85) |
|
| ||||
| Sex, n (%) | ||||
| Male | 39 (74) | 43 (78) | 413 (75) | 395 (72) |
| Female | 14 (26) | 12 (22) | 137 (25) | 151 (28) |
|
| ||||
| IMDC risk factors, n (%) b | 1 (2.0) | 1 (2.0) | 125 (23) | 124 (23) |
| Favorable (0) c | 26 (49) | 32 (58) | 334 (61) | 333 (61) |
| Intermediate (1–2) | 26 (49) | 22 (40) | 91 (17) | 89 (16) |
| Poor (3–6) | ||||
|
| ||||
| Region, n (%) | ||||
| United States | 17 (32) | 11 (20) | 154 (28) | 153 (28) |
| Canada/Europe | 16 (30) | 22 (40) | 201 (37) | 199 (36) |
| Rest of the world | 20 (38) | 22 (40) | 195 (35) | 194 (36) |
|
| ||||
| Prior nephrectomy, n (%) | 0 | P0 | 453 (82) | 437 (80) |
|
| ||||
| Sites with target/nontarget tumors, n (%) d | 2 (4.0) | 1 (2.0) | 123 (22) | 118 (22) |
| 1 | 51 (96) | 54 (98) | 427 (78) | 427 (78) |
| ≥2 | ||||
|
| ||||
| Sites of metastasis, n (%) e | ||||
| Lung | 35 (66) | 33 (60) | 381 (69) | 373 (68) |
| Lymph node | 17 (32) | 32 (58) | 246 (45) | 268 (49) |
| Bone f | 14 (26) | 18 (33) | 112 (20) | 119 (22) |
| Liver | 14 (26) | 10 (18) | 99 (18) | 107 (20) |
|
| ||||
| Quantifiable tumor PD-L1 expression, n (%) | N = 48 | N = 54 | N = 499 | N = 503 |
| <1% | 36 (75) | 40 (74) | 386 (77) | 376 (75) |
| ≥1% | 12 (25) | 14 (26) | 113 (23) | 127 (25) |
IMDC = International Metastatic Renal Cell Carcinoma Database Consortium; NIVO + IPI = nivolumab plus ipilimumab; SUN = sunitinib.
Information shown is based on data collected using an interactive voice-response system.
The case report form was the source for the baseline IMDC score.
Two patients in the subgroup without prior nephrectomy and with an evaluable primary tumor were classified as favorable risk per the case report form. Both patients were determined to have one IMDC risk factor present, which was <1 yr from the time of diagnosis to first dose, consistent with intermediate risk categorization. Hence, these patients were not excluded from the current analysis.
The number of target or nontarget tumors at baseline was not reported for one intent-to-treat patient in the SUN arm.
Includes both target and nontarget tumors.
Bone with and without soft-tissue component.