Overall Survival Curve

Median overall survival not reached in either arm after 40.9 months median follow-up1

Overall Survival1

Overall Survival1

Overall Response Rate Graph

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 Table

Best Overall Response Rate Table2

Best Overall Response as Assessed by INV or IRC2
 IRC AssessmentINV Assessment

Best Response, n (%)

Acalabrutinib  

(n=268)

Ibrunitib

(n=265)

Acalabrutinib  

(n=268)

Ibrunitib

(n=265)

CR5 (1.9)8 (3)25 (9.3)26 (9.8)
CRi002 (0.7)0
nPR2 (0.7)3 (1.1)00
PR210 (78.4)193 (72.8)205 (76.5)186 (70.2)
PRL6 (2.2)8 (3.0)16 (6.0)25 (9.4)
SD29 (10.8)27 (10.2)4 (1.5)9 (3.4)
PD2 (0.7)6 (2.3)3 (1.1)4 (1.5)
Unknown14 (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

1. Byrd JC, Hillmen P, Ghia P, et al. First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic lymphoma [oral presentation]. Presented at: American Society of Clinical Oncology (ASCO) Virtual Annual Meeting; June 4-8, 2021. Chicago, IL. Abstract 7500.
2. Byrd JC, Hillmen P, Ghia P, et al.  Acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia: Results of the first randomized Phase III trial. J. Clin. Oncol. 2021. https://doi.org/10.1200/JCO.21.01210.
3. Hallek M, Cheson BD, Catovsky D, et al.  Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute–Working Group 1996 guidelines. Blood. 2008; 111 (12):5446-5456.

Disclaimers

Please note that this content may contain some data and/or patient populations which are considered off-label in your country. Providing this information does not constitute any recommendation for use. AstraZeneca is providing this material as an information service and professional courtesy. 

Document ID: b5f1a3c0-28eb-4186-8709-e3ddba7b6695
Last updated: 17-April-2023

©2023 AstraZeneca. All rights reserved.