Additional Endpoints
Median overall survival not reached in either arm after 40.9 months median follow-up1
Overall Survival1
Overall Survival1
Exploratory Analyses: Overall Response Rate2
Overall Response Rate2
Overall Response Rate2
Note: ORR was defined as the proportion of patients who achieved a best overall response assessment of CR, CRi, nPR, and PR according to the IWCLL 2008 criteria3
Best Overall Response Rate Table2
| IRC Assessment | INV Assessment | |||
Best Response, n (%) | Acalabrutinib (n=268) | Ibrunitib (n=265) | Acalabrutinib (n=268) | Ibrunitib (n=265) |
| CR | 5 (1.9) | 8 (3) | 25 (9.3) | 26 (9.8) |
| CRi | 0 | 0 | 2 (0.7) | 0 |
| nPR | 2 (0.7) | 3 (1.1) | 0 | 0 |
| PR | 210 (78.4) | 193 (72.8) | 205 (76.5) | 186 (70.2) |
| PRL | 6 (2.2) | 8 (3.0) | 16 (6.0) | 25 (9.4) |
| SD | 29 (10.8) | 27 (10.2) | 4 (1.5) | 9 (3.4) |
| PD | 2 (0.7) | 6 (2.3) | 3 (1.1) | 4 (1.5) |
| Unknown | 14 (5.2) | 20 (7.5) | 13 (4.9) | 15 (5.7) |
ORR (95%CI) | 217 (81.0) (75.8, 85.2) | 204 (77.0) (71.5, 81.6) | 232 (86.6) (82.0, 90.1) | 212 (80.0) (74.8, 84.4) |
Note: ORR was defined as the proportion of patients who achieved a best overall response assessment of CR, CRi, nPR, and PR according to the iwCLL 2008 criteria.3
Abbreviations
CI = confidence interval
;CR = complete response
;CRi = complete response with incomplete bone marrow recovery
;HR = hazard ratio
;INV = investigator
;IRC = independent review committee
;iwCLL = international workshop on CLL
;NE = not estimable
;nPR= nodular partial response
;ORR = overall response rate
;OS = overall survival
;PD = progressive disease
;PR = partial response
;PRL = PR with lymphocytosis
;SD = stable disease
References
Document ID: b5f1a3c0-28eb-4186-8709-e3ddba7b6695
Last updated: 17-April-2023