Comparative Efficacy and Safety of Acalabrutinib Monotherapy in Chronic Lymphocytic Leukemia: A Systematic Review and Meta-Analysis
Author(s)
Muhammed F. KT1, Beema T. Yoosuf, PhD2, Dipika Bansal, MD3.
1PhD Research Scholar, National Institute of Pharmaceutical Education and Research, Mohali, India, 2NIPER, Mohali, India, 3National Institute of Pharmaceutical Education and Research, Mohali SAS Nagar, India.
1PhD Research Scholar, National Institute of Pharmaceutical Education and Research, Mohali, India, 2NIPER, Mohali, India, 3National Institute of Pharmaceutical Education and Research, Mohali SAS Nagar, India.
OBJECTIVES: Chronic lymphocytic leukemia (CLL) is a common malignancy in adults, with a variable clinical course and a high risk of immune dysfunction and secondary cancers. Bruton's tyrosine kinase (BTK) inhibitors, particularly acalabrutinib, have being considered as a promising treatment for CLL, especially in patients of high-risk genetic aberrations. This meta-analysis evaluates the comparative efficacy and safety of acalabrutinib monotherapy in CLL patients across randomized controlled trials (RCTs)
METHODS: A comprehensive systematic review of RCTs comparing acalabrutinib monotherapy to control treatments in CLL patients was undertaken. A comprehensive search was carried out across PubMed, Embase, and Scopus databases. Data on efficacy endpoints, such as progression-free survival (PFS) and overall survival (OS), as well as treatment-emergent adverse events (TEAEs), were extracted. Random-effects models were used to generate hazard ratios (HR) for efficacy outcomes and TEAE associated risk ratios (RR).
RESULTS: A total of three RCTs, involving 1199 patients, met inclusion criteria. Acalabrutinib monotherapy significantly improved OS compared to control treatments (HR = 0.7460, 95% CI: 0.5842 to 0.9525, p = 0.0188). However, the effect on PFS was marginally non-significant (HR = 0.3868, 95% CI: 0.1471 to 1.0168, p = 0.0541). The safety profile of acalabrutinib showed a lower incidence of severe neutropenia compared to controls, but higher rates of anemia and pneumonia. Acalabrutinib also exhibited an increased risk of cardiac events, though this was not statistically significant.
CONCLUSIONS: Acalabrutinib monotherapy offers significant survival benefits over control treatments in CLL, with a generally favourable safety profile. However, concerns regarding anemia, pneumonia, and cardiac events highlight the need for careful monitoring in clinical practice. These findings support acalabrutinib as an effective treatment option, particularly for patients with high-risk CLL. Further studies are needed to address long-term safety and optimal combination strategies.
METHODS: A comprehensive systematic review of RCTs comparing acalabrutinib monotherapy to control treatments in CLL patients was undertaken. A comprehensive search was carried out across PubMed, Embase, and Scopus databases. Data on efficacy endpoints, such as progression-free survival (PFS) and overall survival (OS), as well as treatment-emergent adverse events (TEAEs), were extracted. Random-effects models were used to generate hazard ratios (HR) for efficacy outcomes and TEAE associated risk ratios (RR).
RESULTS: A total of three RCTs, involving 1199 patients, met inclusion criteria. Acalabrutinib monotherapy significantly improved OS compared to control treatments (HR = 0.7460, 95% CI: 0.5842 to 0.9525, p = 0.0188). However, the effect on PFS was marginally non-significant (HR = 0.3868, 95% CI: 0.1471 to 1.0168, p = 0.0541). The safety profile of acalabrutinib showed a lower incidence of severe neutropenia compared to controls, but higher rates of anemia and pneumonia. Acalabrutinib also exhibited an increased risk of cardiac events, though this was not statistically significant.
CONCLUSIONS: Acalabrutinib monotherapy offers significant survival benefits over control treatments in CLL, with a generally favourable safety profile. However, concerns regarding anemia, pneumonia, and cardiac events highlight the need for careful monitoring in clinical practice. These findings support acalabrutinib as an effective treatment option, particularly for patients with high-risk CLL. Further studies are needed to address long-term safety and optimal combination strategies.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PT39
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology