Best overall confirmed response per RECIST V.1.1 in all patients with IMDC I/P-risk sRCC and by tumor PD-L1 expression levels
| Patients with I/P risk sRCC | Patients with I/P risk sRCC and PD-L1 ≥1 | Patients with I/P risk sRCC and PD-L1 <1% | ||||
| NIVO+IPI (n=74) | SUN (n=65) | NIVO+IPI (n=36) | SUN (n=33) | NIVO+IPI (n=35) | SUN (n=29) | |
| Confirmed ORR (95% CI), % | 60.8 (48.8 to 72.0) | 23.1 (13.5 to 35.2) | 69.4 (51.9 to 83.7) | 24.2 (11.1 to 42.3) | 54.3 (36.6 to 71.2) | 20.7 (8.0 to 39.7) |
| P value | <0.0001 | – | – | |||
| Best overall response, n (%) | ||||||
| Complete response | 17 (23.0) | 4 (6.2) | 9 (25.0) | 3 (9.1) | 8 (22.9) | 1 (3.4) |
| Partial response | 28 (37.8) | 11 (16.9) | 16 (44.4) | 5 (15.2) | 11 (31.4) | 5 (17.2) |
| Stable disease | 8 (10.8) | 28 (43.1) | 4 (11.1) | 13 (39.4) | 4 (11.4) | 13 (44.8) |
| Progressive disease | 15 (20.3) | 13 (20.0) | 5 (13.9) | 9 (27.3) | 9 (25.7) | 4 (13.8) |
| Unable to determine/not reported | 6 (8.1) | 9 (13.8) | 2 (5.6) | 3 (9.1) | 3 (8.6) | 6 (20.7) |
I/P, intermediate/poor; NIVO+IPI, nivolumab plus ipilimumab; ORR, objective response rate; PD-L1, programmed death ligand 1; RECIST, Response Evaluation Criteria in Solid Tumors; sRCC, sarcomatoid renal cell carcinoma; SUN, sunitinib.