Patient Exposure (28.3 Month Follow up)1 

Treatment Discontinuations

Despite the longer treatment duration in the acala-containing arms, the frequency of discontinuations due to AEs was not higher1

Treatment Discontinuations1
 Acala-O (N = 179)
 O-Clb (N = 177)
VariableAcalaO

Acala 

(n=179)

OClb
Duration of treatment, median (range), monthsa

27.7 

(25.0-32.8)

5.5

(5.5-5.6)

27.7

(24.8-33.0)

5.6

(5.5-5.9)

5.5

(5.5-5.7)

Discontinued regimen, n (%)37 (20.7)36 (20.1)32 (18.1)
  • Adverse event
20 (11.2)16 (8.9)25 (14.1)
  • Lost to follow-up
01 (0.6)1 (0.6)
  • CLL progressive disease
6 (3.4)7 (3.9)3 (1.7)
  • Withdrawal of consent

1 (0.6)

1 (0.6)1 (0.6)
  • Investigator's decision
4 (2.2)5 (2.8)1 (0.6)
  • Other
4 (2.2)b 3 (1.7)c0
AEs, n (%)
  • Leading to dose interruptions
60 (33.7)18 (10.1)28 (15.6)21 (12.4)37 (21.9)
  • Leading to dose reductions
14 (7.9)-5 (2.8)-48 (28.4)
aContinuous acalabrutinib treatment resulted in a longer reporting period for Acala-O, and Acala vs O-Clb; bOther: patient decision (n=1), dose interruption >28 days (n=2; anemia and pneumonia), and risk of bleeding while taking aspirin and clopidogrel (n=1); cOther: patient decision (n=1), Richter transformation (n=1), and dose interruption >28 days (n=1; grade 4 thrombocytopenia).

Time to Next Treatment

A higher percentage of patients on O-Clb required a subsequent treatment versus patients on acalabrutinib regimens1

Median time to next treatment was not reached in any group1

Kaplan–Meier Assessments of Time to Next Treatment.1

Kaplan–Meier Assessments of Time to Next Treatment.1

Abbreviations

Acala = acalabrutinib

;

AE = adverse event

;

Clb = chlorambucil

;

CI = confidence interval

;

O = obinutuzumab

;

vs = versus

References

1. 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

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