Summary

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• Calquence (acalabrutinib) is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
• This summary is based on the review of three systematic review(s)/meta-analysis(es). ^[1-3]
• The pooled Overall Response Rate (ORR) for new-generation BTKi, including acalabrutinib, was 92% (95% CI, 89-95%), with a Complete Response (CR) rate of 10% (95% CI, 6-14%). Zanubrutinib monotherapy showed higher ORR/CR rates and 24-month OS/PFS compared to acalabrutinib monotherapy.
• Acalabrutinib + obinutuzumab significantly improved Progression-Free Survival (PFS) compared to all comparators, with acalabrutinib monotherapy also showing significant PFS improvement over most comparators. However, Overall Survival (OS) hazard ratios for acalabrutinib were often not significant due to wide credible intervals.
• Acalabrutinib demonstrated significantly increased ORR, CR rates, PFS, and OS when compared to various other therapies (e.g., ibrutinib, bortezomib, lenalidomide) in relapsed/refractory mantle cell lymphoma (MCL) patients.
• Severe adverse events commonly associated with treatments included cytopenia and hypertension. Higher adverse event rates were observed with BTKi combination therapies compared to monotherapies, with zanubrutinib possibly offering better safety in monotherapy contexts.
• Acalabrutinib demonstrated a safety profile similar to or better than monotherapies, though it presented an increased risk of infections compared to bendamustine + rituximab, and a higher risk of anemia compared to lenalidomide + rituximab and ibrutinib + rituximab. There was no explicit safety profile detailed in one of the studies.
• Specific population types benefiting from acalabrutinib include those under 65 years old, treatment-naive CLL patients, fludarabine-ineligible CLL patients, and relapsed/refractory MCL patients, with increased efficacy and improved safety profiles observed in these subgroups.