Overall response rate, combined primary and extension studies (N = 64)
| Response, n (%) . | Total (N = 64) . | Del(17p)/TP53 mutation* . | IGHV mutation* . | ||
|---|---|---|---|---|---|
| Either (N = 9) . | Neither (N = 52) . | Mutated (N = 23) . | Unmutated (N = 37) . | ||
| CR | 12 (18.8) | 3 (33.3) | 7 (13.5) | 7 (30.4) | 3 (8.1) |
| PR | 50 (78.1) | 6 (66.7) | 43 (82.7) | 15 (65.2) | 33 (89.2) |
| PR-L | 0 | 0 | 0 | 0 | 0 |
| SD | 0 | 0 | 0 | 0 | 0 |
| PD | 0 | 0 | 0 | 0 | 0 |
| NE | 2 (3.1) | 0 | 2 (3.8) | 1 (4.3) | 1 (2.7) |
| ORR† | 62 (96.9) | 9 (100.0) | 50 (96.2) | 22 (95.7) | 36 (97.3) |
| 95% CI‡ | 89.2-99.6 | 66.4-100 | 86.8-99.5 | 78.1-99.9 | 85.8-99.9 |
| Response, n (%) . | Total (N = 64) . | Del(17p)/TP53 mutation* . | IGHV mutation* . | ||
|---|---|---|---|---|---|
| Either (N = 9) . | Neither (N = 52) . | Mutated (N = 23) . | Unmutated (N = 37) . | ||
| CR | 12 (18.8) | 3 (33.3) | 7 (13.5) | 7 (30.4) | 3 (8.1) |
| PR | 50 (78.1) | 6 (66.7) | 43 (82.7) | 15 (65.2) | 33 (89.2) |
| PR-L | 0 | 0 | 0 | 0 | 0 |
| SD | 0 | 0 | 0 | 0 | 0 |
| PD | 0 | 0 | 0 | 0 | 0 |
| NE | 2 (3.1) | 0 | 2 (3.8) | 1 (4.3) | 1 (2.7) |
| ORR† | 62 (96.9) | 9 (100.0) | 50 (96.2) | 22 (95.7) | 36 (97.3) |
| 95% CI‡ | 89.2-99.6 | 66.4-100 | 86.8-99.5 | 78.1-99.9 | 85.8-99.9 |
CI, confidence interval; CR, complete response; IGHV, immunoglobulin heavy-chain variable region; NE, not evaluable; PD, progressive disease; PR, partial response; PR-L, PR with lymphocytosis; SD, stable disease.
Patients with missing mutation data were not included.
ORR = CR + PR.
95% exact binomial CI of ORR.