Objective response per RECIST V.1.1 by investigator review by IMDC risk score (response-evaluable population; n=49*)
| IMDC risk score | Total | ||||
| Favorable | Intermediate | Poor | Intermediate/poor | ||
| Patients, n | 17 | 22 | 10 | 32 | 49 |
| ORR (CR+PR) | 9 (52.9) | 7 (31.8) | 1 (10.0) | 8 (25.0) | 17 (34.7) |
| 95% CI | 27.8 to 77.0 | 13.9 to 54.9 | 0.3 to 44.5 | 11.5 to 43.4 | 21.7 to 49.6 |
| CR | 2 (11.8) | 1 (4.5) | 0 | 1 (3.1) | 3 (6.1) |
| PR | 7 (41.2) | 6 (27.3) | 1 (10.0) | 7 (21.9) | 14 (28.6) |
| SD | 7 (41.2) | 8 (36.4) | 4 (40.0) | 12 (37.5) | 19 (38.8) |
| CBR (CR+PR+SD≥7 weeks) | 16 (94.1) | 15 (68.2) | 5 (50.0) | 20 (62.5) | 36 (73.5) |
| PD | 1 (5.9) | 7 (31.8) | 5 (50.0) | 12 (37.5) | 13 (26.5) |
| Time to response, median months† | 4.0 | 4.1 | 1.6 | 3.8 | 4.0 |
| Time to CR, median months† | 4.7 | 1.4 | – | 1.4 | 3.5 |
| Duration of response, median months† | 13.0 | 26.1 | NE | NE | 26.1 |
| Proportion of patients with response lasting at least 6 months (95% CI)† | 77.8 (36.5 to 93.9) | 85.7 (33.4 to 97.9) | 100.0 (100.0 to 100.0) | 87.5 (38.7 to 98.1) | 82.4 (54.7 to 93.9) |
| Proportion of patients with response lasting at least 12 months (95% CI)† | 55.6 (20.4 to 80.5) | 85.7 (33.4 to 97.9) | 100.0 (100.0 to 100.0) | 87.5 (38.7 to 98.1) | 70.6 (43.1 to 86.6) |
| Proportion of patients with response ≥24 months (95% CI)† | 33.3 (7.8 to 62.3) | 71.4 (25.8 to 92.0) | 100.0 (100.0 to 100.0) | 75.0 (31.5 to 93.1) | 51.5 (25.7 to 72.3) |
Data cut-off: January 8, 2021. Numbers are n (%) unless otherwise specified.
*Response-evaluable population includes patients who have measurable disease (per RECIST V.1.1) at baseline and have at least one postbaseline assessment of tumor response.
†Based on patients who responded. The median duration of response and the proportion of patients with response are from Kaplan-Meier estimates.
CBR, clinical benefit rate; CR, complete response; IMDC, International Metastatic RCC Database Consortium; NE, not estimable; ORR, objective response rate; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.