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 immunoglobulin heavy chain variable region (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 PFS and 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.