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Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in mature B-cell

Richard R Furman1, John C Byrd2, Roger G Owen3

  • 1Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY, USA. rrfurman@med.cornell.edu.

Leukemia
|April 28, 2021
PubMed

Insights

Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, demonstrates good tolerability in mature B-cell malignancies. Pooled safety data show manageable adverse events, supporting its use as a long-term therapy option.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Bruton tyrosine kinase (BTK) inhibitors are effective treatments for B-cell malignancies.
  • Acalabrutinib is a next-generation BTK inhibitor known for its potency and selectivity.

Purpose of the Study:

  • To evaluate the tolerability and safety profile of acalabrutinib monotherapy in patients with mature B-cell malignancies.
  • To identify common and serious adverse events associated with acalabrutinib treatment.

Main Methods:

  • Pooled safety data from 1040 patients across nine clinical studies of acalabrutinib monotherapy.
  • Analysis included treatment-naïve and relapsed/refractory patients with mature B-cell malignancies.
  • Assessment of adverse events (AEs), serious adverse events (SAEs), and treatment discontinuations.

Main Results:

  • The most frequent AEs were headache (38%) and diarrhea (37%).
  • Serious AEs occurred in 39% of patients, with pneumonia being the most common (6%).
  • AEs led to discontinuation in 9% of patients; no new late toxicities were observed.

Conclusions:

  • Acalabrutinib exhibits a favorable tolerability profile in patients with mature B-cell malignancies.
  • The safety data support acalabrutinib's suitability for long-term treatment regimens.
  • Consistent safety findings across studies reinforce acalabrutinib's role in B-cell malignancy therapy.

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