Response rates to acalabrutinib
| . | 100 mg BID (n = 24) (%) . | 200 mg QD (n = 24) (%) . | Total (n = 48) (%) . |
|---|---|---|---|
| ORR | 23 (95.8) | 19 (79.2) | 42 (87.5) |
| 95% CI | (78.9-99.9) | (57.9-92.9) | (74.8-95.3) |
| CR | 1 (4.2) | 3 (12.5) | 4 (8.3) |
| PR | 22 (91.7) | 16 (66.7) | 38 (79.2) |
| PRL | 0 | 0 | 0 |
| Age, y | |||
| <65 | 11/11 (100.0) | 14/16 (87.5) | 25/27 (92.6) |
| (71.5-100.0) | (61.7-98.5) | (75.7-99.1) | |
| ≥65 | 12/13 (92.3) | 5/8 (62.5) | 17/21 (81.0) |
| (64.0-99.8) | (24.5-91.5) | (58.1-94.6) | |
| Rai stage | |||
| Intermediate | 14/14 (100.0) | 10/11 (90.9) | 24/25 (96.0) |
| (76.8-100.0) | (58.7-99.8) | (79.7-99.9) | |
| High | 7/8 (87.5) | 7/11 (63.6) | 14/19 (73.7) |
| (47.4-99.7) | (30.8-89.1) | (48.8-90.9) | |
| Prior treatment | |||
| No | 6/6 (100.0) | 8/10 (80.0) | 14/16 (87.5) |
| (54.1-100.0) | (44.4-97.5) | (61.7-98.5) | |
| Yes | 17/18 (94.4) | 11/14 (78.6) | 28/32 (87.5) |
| (72.7-99.9) | (49.2-95.3) | (71.0-96.5) | |
| Del 17p/TP53 mutation | |||
| No | 14/15 (93.3) | 11/12 (91.7) | 25/27 (92.6) |
| (68.1-99.8) | (61.5-99.8) | (75.7-99.1) | |
| Yes | 4/4 (100.0) | 6/9 (66.7) | 10/13 (76.9) |
| (39.8-100.0) | (29.9-92.5) | (46.2-95.0) | |
| NOTCH1 mutation | |||
| No | 11/12 (91.7) | 8/11 (72.7) | 19/23 (82.6) |
| (61.5-99.8) | (39.0-94.0) | (61.2-95.1) | |
| Yes | 8/8 (100.0) | 10/11 (90.9) | 18/19 (94.7) |
| (63.1-100.0) | (58.7-99.8) | (74.0-99.9) |
| . | 100 mg BID (n = 24) (%) . | 200 mg QD (n = 24) (%) . | Total (n = 48) (%) . |
|---|---|---|---|
| ORR | 23 (95.8) | 19 (79.2) | 42 (87.5) |
| 95% CI | (78.9-99.9) | (57.9-92.9) | (74.8-95.3) |
| CR | 1 (4.2) | 3 (12.5) | 4 (8.3) |
| PR | 22 (91.7) | 16 (66.7) | 38 (79.2) |
| PRL | 0 | 0 | 0 |
| Age, y | |||
| <65 | 11/11 (100.0) | 14/16 (87.5) | 25/27 (92.6) |
| (71.5-100.0) | (61.7-98.5) | (75.7-99.1) | |
| ≥65 | 12/13 (92.3) | 5/8 (62.5) | 17/21 (81.0) |
| (64.0-99.8) | (24.5-91.5) | (58.1-94.6) | |
| Rai stage | |||
| Intermediate | 14/14 (100.0) | 10/11 (90.9) | 24/25 (96.0) |
| (76.8-100.0) | (58.7-99.8) | (79.7-99.9) | |
| High | 7/8 (87.5) | 7/11 (63.6) | 14/19 (73.7) |
| (47.4-99.7) | (30.8-89.1) | (48.8-90.9) | |
| Prior treatment | |||
| No | 6/6 (100.0) | 8/10 (80.0) | 14/16 (87.5) |
| (54.1-100.0) | (44.4-97.5) | (61.7-98.5) | |
| Yes | 17/18 (94.4) | 11/14 (78.6) | 28/32 (87.5) |
| (72.7-99.9) | (49.2-95.3) | (71.0-96.5) | |
| Del 17p/TP53 mutation | |||
| No | 14/15 (93.3) | 11/12 (91.7) | 25/27 (92.6) |
| (68.1-99.8) | (61.5-99.8) | (75.7-99.1) | |
| Yes | 4/4 (100.0) | 6/9 (66.7) | 10/13 (76.9) |
| (39.8-100.0) | (29.9-92.5) | (46.2-95.0) | |
| NOTCH1 mutation | |||
| No | 11/12 (91.7) | 8/11 (72.7) | 19/23 (82.6) |
| (61.5-99.8) | (39.0-94.0) | (61.2-95.1) | |
| Yes | 8/8 (100.0) | 10/11 (90.9) | 18/19 (94.7) |
| (63.1-100.0) | (58.7-99.8) | (74.0-99.9) |
CR, complete response; PR, partial response; PRL, partial response with lymphocytosis.