Secondary Endpoint - Atrial Fibrillation

Incidence of Any Grade Atrial fibrillation/flutter was Significantly Lower with Acalabrutinib1

Incidence of Any Grade Atrial Fibrillation/Flutter1 
 Any grade1
 Acalabrutinib (n=266)Ibrutinib (n=263)
Atrial fibrillation/flutter25 (9.4)a,b42 (16.0)b
Events/100 person-months0.3660.721
Time to onset, median (range), months28.8 (0.4-52.0)16.0 (0.5-48.3)
Leading to treatment discontinuationc07 (16.7)
Afib/flutter incidence among patients without prior history of afib/flutter15/243 (6.2)37/249 (14.9)
aDifference in any-grade incidence rates: -6.6% (95% CI -12.2 to -0.9), P=0.02; bGrade ≥3 afib/flutter was reported in 13 (4.9%) in the acalabrutinib arm vs 10 (3.8%) in the ibrutinib arm; cAmong patients with events of afib/flutter.

Cumulative Incidence Bar Graph of AF

Cumulative Incidence of Any Grade AF was Lower for Acalabrutinib at Each Time Point2

Incidence of Any Grade AF/Flutter2

Incidence of Any Grade AF/Flutter2

Incidence Bar Graph of AF in Patient Subgroups

Incidence Bar Graph of AF in Patient Subgroups2

Incidence of AF/Flutter in Patient subgroups2

Incidence of AF/Flutter in Patient subgroups2

Hypertension and Selected Cardiac Events

Hypertension and Selected Cardiac Events3

Hypertension and Selected Cardiac Events3

Acalabrutinib (n=266)
Ibrutinib (n=263)
EventsAny gradeGrade ≥3Any GradeGrade ≥3
Hypertension eventsa 25 (9.4)11 (4.1)61 (23.2)24 (9.1)
  • Events/100 person-months
0.4440.1331.2430.435
  • Patients with a history of hypertension
16/25 (64.0)9/11 (81.8)30/61 (49.2)16/24 (66.7)
Any cardiac event64 (24.1)23 (8.6)79 (30.0)25 (9.5)
  • Ventricular arrhythmia or cardiac arrest
1 (0.4)1 (0.4)5 (1.9)3 (1.1)
  • Cardiorespiratory arrest
1 (0.4)1 (0.4)00
  • Cardiac arrest
002 (0.8)2 (0.8)
  • Ventricular arrhythmia
001 (0.4)0
  • Ventricular extrasystoles
001 (0.4)0
  • Ventricular fibrillation
001 (0.4)1 (0.4)

 Note: Data are n (%) unless otherwise specified. 


aIncludes events with the preferred terms of hypertension, blood pressure increased, and blood pressure systolic increased; two-sided p value on the basis of Barnard’s exact test without multiplicity adjustment, p=0.001 (any grade) and p=0.0214 (grade ≥3).

Cumulative Incidence Bar Graph of HTN

Cumulative Incidence of Any-Grade HTN was Lower with Acalabrutinib at Each Time Point2

Incidence of Any Grade HTN2

Incidence of Any Grade HTN2

Incidence Bar Graph of HTN in Subgroups

Incidence Bar Graph of HTN in Subgroups2

Incidence of HTN in Patient Subgroups2

Incidence of HTN in Patient Subgroups2

Cardiac Cumulative Incidence Curves

Cumulative Incidence KM Curves for Select AEs3 

Abbreviations

AF = atrial fibrillation

;

Afib/flutter = atrial fibrillation/flutter

;

CI = confidence interval

;

HR = hazard ratio

;

HTN = hypertension

;

No. = number

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. Seymour JF, Byrd JC, Hillmen P, et al.  Characterization of Bruton tyrosine kinase inhibitor (BTKi)-related adverse events in a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia (CLL) [poster]. Presented at American Society of Hematology (ASH) Annual Meeting; December 11-14, 2021; Atlanta, Georgia. Abs. 3721.
3. 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.

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