Table 1:
Demographic and clinical characteristics at baseline in the intention-to-treat population
| Characteristic* | Nivolumab plus cabozantinib (N=323) | Sunitinib (N=328) |
|---|---|---|
| Median age (range), years | 62 (29–90) | 61 (28–86) |
| Sex | ||
| Male | 249 (77) | 232 (71) |
| Female | 74 (23) | 96 (29) |
| Race | ||
| White | 267 (83) | 266 (81) |
| Black or African American | 1 (<1) | 4 (1) |
| Asian | 26 (8) | 25 (8) |
| Other/not reported† | 29 (9) | 33 (10) |
| Ethnicity | ||
| Hispanic or Latino | 38 (12) | 39 (12) |
| Not Hispanic or Latino | 149 (46) | 151 (46) |
| Not reported | 136 (42) | 138 (42) |
| Karnofsky performance status‡ | ||
| <90 | 66 (20) | 85 (26) |
| 90–100 | 257 (80) | 241 (73) |
| Not reported | 0 | 2 (<1) |
| IMDC prognostic score (IRT) | ||
| Favourable (0) | 74 (23) | 72 (22) |
| Intermediate (1–2) | 188 (58) | 188 (57) |
| Poor (3–6) | 61 (19) | 68 (21) |
| Region (IRT) | ||
| US/Europe | 158 (49) | 161 (49) |
| Rest of the world | 165 (51) | 167 (51) |
| Tumour PD-L1 expression | ||
| ≥1% | 83 (26) | 83 (25) |
| <1% or indeterminate | 240 (74) | 245 (75) |
| Not reported | 0 | 0 |
| No. of organ sites with target/non-target lesions | ||
| 1 | 63 (20) | 69 (21) |
| ≥2 | 259 (80) | 256 (78) |
Data are n (%) unless otherwise reported.
The ITT population includes all patients who underwent randomisation. The IMDC prognostic risk score, PD-L1 status, and geographic region (stratification factors) were recorded at screening by means of IRT in ITT patients, whereas PD-L1 status was reported per case report form in subgroups.
Other race included American Indian and Alaska Native, and answers such as Hispanic, Latino, unknown, not specified.
Karnofsky performance status scores range from 0–100, with lower scores indicating greater disability.
Data are for tumour sites defined at baseline by the investigators according to RECIST version 1.1.
IMDC=International Metastatic Renal Cell Carcinoma Database Consortium. IRT=interactive response technology. ITT=intention–to-treat. PD-L1=programmed death ligand 1. RECIST=Response Evaluation Criteria in Solid Tumors.
In part published in Choueiri TK, Powles T, Burotto M, et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2021; 384: 829–41.