Investigator-assessed responses
| . | Ibrutinib intolerant (cohort 1) . | Acalabrutinib intolerant∗ (cohort 2) . | Total . |
|---|---|---|---|
| ORR and DCR | |||
| n | 43 | 24 | 67 |
| ORR, n (%) [95% CI]† | 30 (69.8) [53.9-82.8] | 13 (54.2) [32.8-74.4] | 43 (64.2) [51.5-75.5] |
| DCR, n (%) [95% CI]‡ | 41 (95.3) [84.2-99.4] | 22 (91.7) [73.0-99.0] | 63 (94.0)[85.4-98.3] |
| BOR, n (%) | |||
| CR | 1 (2.3) | 0 | 1 (1.5) |
| PR | 25 (58.1) | 11 (45.8) | 36 (53.7) |
| PR with lymphocytosis | 4 (9.3) | 2 (8.3) | 6 (9.0) |
| SD | 11 (25.6) | 9 (37.5) | 20 (29.9) |
| PD | 1 (2.3) | 1 (4.2) | 2 (3.0) |
| Not assessed | 1 (2.3)§ | 1 (4.2)|| | 2 (3.0) |
| Time to first overall response | |||
| n | 30 | 13 | 43 |
| Median (range), mo | 2.9 (2.6-28.1) | 2.8 (2.7-7.9) | 2.9 (2.6-28.1) |
| Time to BOR | |||
| n | 30 | 13 | 43 |
| Median (range), mo | 5.8 (2.6-28.1) | 2.9 (2.7-21.1) | 5.6 (2.6-28.1) |
| PFS¶ | |||
| n | 43 | 24 | 67 |
| 12-Month event-free rate (95% CI) | 90.2 (76.0-96.2) | 75.2 (45.8-90.1) | 86.1 (74.1-92.8) |
| DoR¶ | |||
| n | 30 | 13 | 43 |
| 12-Month event-free rate (95% CI) | 89.0 (69.6-96.3) | 75.0 (40.8-91.2) | 84.6 (68.9-92.8) |
| . | Ibrutinib intolerant (cohort 1) . | Acalabrutinib intolerant∗ (cohort 2) . | Total . |
|---|---|---|---|
| ORR and DCR | |||
| n | 43 | 24 | 67 |
| ORR, n (%) [95% CI]† | 30 (69.8) [53.9-82.8] | 13 (54.2) [32.8-74.4] | 43 (64.2) [51.5-75.5] |
| DCR, n (%) [95% CI]‡ | 41 (95.3) [84.2-99.4] | 22 (91.7) [73.0-99.0] | 63 (94.0)[85.4-98.3] |
| BOR, n (%) | |||
| CR | 1 (2.3) | 0 | 1 (1.5) |
| PR | 25 (58.1) | 11 (45.8) | 36 (53.7) |
| PR with lymphocytosis | 4 (9.3) | 2 (8.3) | 6 (9.0) |
| SD | 11 (25.6) | 9 (37.5) | 20 (29.9) |
| PD | 1 (2.3) | 1 (4.2) | 2 (3.0) |
| Not assessed | 1 (2.3)§ | 1 (4.2)|| | 2 (3.0) |
| Time to first overall response | |||
| n | 30 | 13 | 43 |
| Median (range), mo | 2.9 (2.6-28.1) | 2.8 (2.7-7.9) | 2.9 (2.6-28.1) |
| Time to BOR | |||
| n | 30 | 13 | 43 |
| Median (range), mo | 5.8 (2.6-28.1) | 2.9 (2.7-21.1) | 5.6 (2.6-28.1) |
| PFS¶ | |||
| n | 43 | 24 | 67 |
| 12-Month event-free rate (95% CI) | 90.2 (76.0-96.2) | 75.2 (45.8-90.1) | 86.1 (74.1-92.8) |
| DoR¶ | |||
| n | 30 | 13 | 43 |
| 12-Month event-free rate (95% CI) | 89.0 (69.6-96.3) | 75.0 (40.8-91.2) | 84.6 (68.9-92.8) |
CI, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration of response; ORR, overall response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.
Includes patients intolerant of ibrutinib and acalabrutinib.
Defined as PR with lymphocytosis or better.
Defined as SD or better.
Patient died prior to first disease assessment.
Patient discontinued study because of AE prior to first disease assessment.
Median PFS and DoR were not reached.