Summary

At a median follow-up of 40.9 months, acalabrutinib was non-inferior to ibrutinib on the primary endpoint of IRC-assessed PFS (HR: 1.00 [95% CI: 0.79, 1.27])1

Acalabrutinib demonstrated lower frequencies of common AEs, grade ≥3 AEs, SAEs, and lower treatment discontinuations due to AEs overall2

  • The incidence of grade ≥3 events were lower with acalabrutinib in high-risk patients with del(17p)
  • Time to treatment discontinuation overall was longer with acalabrutinib

Cardiovascular events were less common with acalabrutinib vs ibrutinib2 

  • Afib/flutter events (any grade) were significantly less frequent with acalabrutinib vs ibrutinib (9.4% vs 16%; P=0.02)
  • Hypertension (any grade) was also less frequent with acalabrutinib vs ibrutinib (9.4% vs 23.2%)

ECIs overall, as well as hypertension and atrial fibrillation/flutter were also less prevalent each year with acalabrutinib2 

Among other secondary endpoints:1

  • Incidence of grade ≥3 infections and Richter transformation were comparable between arms
  • Median OS was not reached in either arm

These results demonstrate that acalabrutinib is better tolerated and has similar efficacy to ibrutinib in patients with previously treated CLL2

Abbreviations

AE = adverse events

;

CI = confidence interval

;

ECI = events of clinical interest

;

HR = hazard ratio

;

IRC = independent review committee 

;

OS = overall survival 

;

PFS = progression free survival

;

SAE = serious adverse events

;

vs = versus

References

1. 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.
2. Hillmen P, Byrd JC, Ghia P, et al. Efficacy and safety of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia: results of a Phase 3 clinical trial [oral presentation]. Presented at: International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Virtual Meeting; September 17-20, 2021. Abs. 1083838.

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