Overall Response Rates

Investigator-assessed ORR1 

CR/CRi rates increased from interim analysis at 28.32 months to 4 years follow up1 (A-O: 24.0% to 30.7%; A: 7.8% to 11.2%)

Investigator-assessed ORR1 

Investigator-assessed ORR1 

Note: ORR is defined as achieving CR, CRi, nPR, or PR per the investigator or IRC assessment per iwCLL 2008 criteria at or before initiation of subsequent anticancer therapy. 

aBased on Cochran-Mantel-Haenzel test with adjustment for 17p deletion status (yes vs no) vs O-Clb; bIncludes CR and CRi; cIncludes PR, nPR, and PRL.

Minimal Residual Disease

MRD Status in Patients with CR/CRi1

Among patients with CR/CRi, higher uMRD rates were sustained at the last 2 timepoints in a higher proportion of patients receiving A-O vs O-Clb (38% vs 9%)1

MRD Status in Patients with CR/CRi1

MRD Status in Patients with CR/CRi1

Notes: MRD was defined as the proportion of subjects with <1 CLL cell in 104 leukocytes. Peripheral blood testing to assess MRD occurred for patients with bone marrow-confirmed CR. Peripheral blood MRD status based on last two timepoints (most recent assessments available by the data cutoff) in patients with CR/CRi. 

Overall Survival

Overall Survival at 46.9 months median follow up1

Median OS not reached in any arm, yet 39% (69/177) of patients in the O-Clb arm crossed over to acalabrutinib1

Overall Survival at 46.9 months median follow up1

Overall Survival at 46.9 months median follow up1

aHazard ratio was based on stratified Cox-Proportional-Hazards model (stratified by del[17p] status).

Abbreviations

A = acalabrutinib

;

CI = confidence interval

;

Clb = chlorambucil

;

CLL = chronic lymphocytic leukemia

;

CR = complete response

;

CRi = CR with incomplete marrow recovery

;

HR = hazard ratio

;

IRC = independent review committee 

;

INV = investigator

;

IwCLL = international workshop on CLL

;

MRD = minimal residual disease

;

NE = not estimable

;

nPR= nodular partial response

;

O = obinutuzumab

;

ORR = overall response rate

;

OS = overall survival 

;

PR = partial response 

;

PRL = partial response with lymphocytosis

;

uMRD = undetectable minimal residual disease

;

vs = versus

References

1. Sharman J, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus obinutuzumab with chlorambucil in treatment-naive chronic lymphocytic leukemia: ELEVATE-TN 4-year follow-up [oral presentation]. Presented at: American Society of Clinical Oncology (ASCO) Virtual Annual Meeting; June 4-8, 2021. Chicago, IL. Abs 7509.
2. Sharman JP, Egyed M, Jurczak W et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment-nave chronic lymphocytic leukemia (ELEVATE TN): a randomized, controlled phase 3 trial [article and supplementary appendix]. Lancet. 2020;395:1278-91.

Document ID: 780f9b60-d375-4516-97d6-9ba58f025de4
Last updated: 17-April-2023

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. 

©2023 AstraZeneca. All rights reserved.