Table 2.
ORR (mRECIST) at Week 16 in all patients and best response (RECIST 1.0) by INV in patients continuously treated with tivozanib.
| ORR at Week 16, n (%) | All nccRCC, n = 46 | Papillary, n = 11 | Chromophobe, n = 2 | Collecting duct, n = 2 | Mixed/unclassified, n = 31 |
|---|---|---|---|---|---|
| PR | 7 (15.2) | 0 | 0 | 1 (50) | 6 (19.4) |
| SD | 22 (47.8) | 9 (81.8) | 2 (100) | 1 (50) | 10 (32.3) |
| PD | 12 (26.1) | 2 (18.2) | 0 | 0 | 10 (32.3) |
| NE | 5 (10.9) | 0 | 0 | 0 | 5 (16.1) |
| Best ORR*, n (%) | All nccRCC, n = 38 | Papillary, n = 8 | Chromophobe, n = 2 | Collecting duct, n = 1 | Mixed/unclassified, n = 27 |
|---|---|---|---|---|---|
| PR | 12 (31.6) | 3 (37.5) | 1 (50) | 1 (100) | 7 (22.6) |
| SD | 16 (42.1) | 4 (50) | 1 (50) | 0 | 11 (40.7) |
| PD | 6 (15.8) | 1 (12.5) | 0 | 0 | 5 (18.5) |
| NE | 4 (10.5) | 0 | 0 | 0 | 4 (14.8) |
| Best confirmed ORR, n (%) | All nccRCC, n = 38 | Papillary, n = 8 | Chromophobe, n = 2 | Collecting duct, n = 1 | Mixed/unclassified, n = 27 |
|---|---|---|---|---|---|
| PR | 8 (21.1) | 2 (25) | 1 (50) | 1 (100) | 4 (14.8) |
| SD | 20 (52.6) | 5 (62.5) | 1 (50) | 0 | 14 (51.9) |
| PD | 6 (15.8) | 1 (12.5) | 0 | 0 | 5 (18.5) |
| NE | 4 (10.5) | 0 | 0 | 0 | 4 (14.8) |
*Includes unconfirmed PR.
Abbreviations: INV, investigator; nccRCC, non-clear cell renal cell carcinoma; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.