Acalabrutinib

(Calquence®)

Calquence®

Drug updated on 10/30/2024

Dosage FormTablets (oral; 100 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
  • Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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Summary
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  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Acalabrutinib demonstrated a high overall response rate (ORR) of 92% and a complete response (CR) rate of 10% across 20 studies. It significantly improved progression-free survival (PFS) and overall survival (OS) in fludarabine-ineligible chronic lymphocytic leukemia (CLL) patients and in relapsed/refractory mantle cell lymphoma (MCL), outperforming treatments such as ibrutinib-obinutuzumab and venetoclax-obinutuzumab.
  • In combination with obinutuzumab, acalabrutinib showed superior PFS compared to ibrutinib-obinutuzumab (IO) and venetoclax-obinutuzumab (VO), particularly in patients with unmutated IGHV status. It was also more effective in treatment-naive CLL patients and those under 65 years old.
  • Common grade ≥3 adverse events with acalabrutinib include cytopenia and hypertension. The incidence of second primary malignancies (SPM), particularly nonmelanoma skin cancers, was 4.7%, with a rate of 2.56 per 100 person-years in the acalabrutinib group versus 1.12 per 100 person-years in the control group.
  • Acalabrutinib monotherapy demonstrated a better safety profile compared to combination therapies, especially in older patients with comorbidities. However, it had an increased risk of infections compared to bendamustine + rituximab and a higher risk of anemia compared to lenalidomide + rituximab and ibrutinib + rituximab.
  • Acalabrutinib demonstrated higher efficacy in treatment-naive CLL patients and those under 65 years of age, with improved progression-free survival (PFS) and overall survival (OS) compared to other treatments. Patients with unmutated IGHV status benefited more from acalabrutinib combined with obinutuzumab. Additionally, BTK inhibitors, including acalabrutinib, were associated with decreased oxygen requirements in COVID-19 patients, although further randomized trials are needed to confirm these findings.

Product Monograph / Prescribing Information

Document TitleYearSource
Calquence (acalabrutinib) Prescribing Information.2024AstraZeneca, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Safety profile of first-line targeted therapies in elderly and/or comorbid chronic lymphocytic leukaemia patients (unfit subpopulation). A systematic review and network meta-analysis2024Critical Reviews in Oncology/Hematology
Efficacy and safety of new-generation Bruton tyrosine kinase inhibitors in chronic lymphocytic leukemia/small lymphocytic lymphoma: a systematic review and meta-analysis2024Annals of Hematology
Molecular-Biology-Driven Frontline Treatment for Chronic Lymphocytic Leukemia: A Network Meta-Analysis of Randomized Clinical Trials2023International Journal of Molecular Sciences
BTK inhibitors for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): A Systematic Review2021Research Square
Acalabrutinib-related second primary malignancies and nonmelanoma skin cancers in patients with chronic lymphocytic leukaemia (CLL): A systematic review and meta-analysis of randomised controlled trials (RCTs)2021EJHaem
Comparison Between Venetoclax-based and Bruton Tyrosine Kinase Inhibitor-based Therapy as Upfront Treatment of Chronic Lymphocytic Leukemia (CLL): A Systematic Review and Network Meta-analysis2021Clinical Lymphoma, Myeloma & Leukemia
Comparative Efficacy of Acalabrutinib in Frontline Treatment of Chronic Lymphocytic Leukemia: A Systematic Review and Network Meta-analysis2020Clinical Therapeutics
Matching-adjusted Indirect Comparisons of the Efficacy and Safety of Acalabrutinib Versus Other Targeted Therapies in Relapsed/Refractory Mantle Cell Lymphoma2019Clinical Therapeutics

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