Summary

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• Brukinsa (zanubrutinib) is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen, 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]
• In chronic lymphocytic leukemia (CLL) patients receiving Bruton tyrosine kinase inhibitors (BTKi), combination therapy and acalabrutinib monotherapy achieved an objective response rate (ORR) greater than 80%, with a progression-free survival (PFS) of over 80% in combination therapy.
• New-generation BTKi-based regimens in CLL/small lymphocytic lymphoma (SLL) patients showed a pooled ORR of 92% and a complete response (CR) rate of 10%, with higher efficacy observed in patients younger than 65, treatment-naive (TN)-CLL, and those receiving combination therapy.
• Zanubrutinib demonstrated an overall ORR of 95.4% in treatment-naive (TN) or relapsed/refractory (R/R) CLL/SLL patients, with significantly higher ORR in the TN group (100%) compared to the R/R group (91%), and superior PFS and overall survival in TN and patients with one prior line of therapy.
• Common adverse events (AEs) for BTKi therapy included diarrhea, hypertension, cardiac events, and neutropenia. Ibrutinib monotherapy had a higher incidence of grade ≥3 adverse reactions (0.77, 95% CI 0.72-0.82), while zanubrutinib monotherapy had a lower incidence of total serious adverse reactions (0.42, 95% CI 0.36-0.47). Most frequent grade ≥3 AEs in long-term follow-up were infections (41.7%), neutropenia (34.1%), and thrombocytopenia (9.4%).
• Combination therapy with BTKi was associated with relatively high AEs rates, including a higher incidence of hypertension in IR (0.38, 95% CI 0.28-0.48) and increased cardiac events with IU therapy. Atrial fibrillation was rare, occurring in 1.9% of patients.
• Higher efficacy was observed in younger patients (<65 years) receiving new-generation BTKi-based therapy, treatment-naive (TN) patients had a higher ORR (100%) and longer progression-free and overall survival compared to relapsed/refractory (R/R) patients, and similar efficacy was noted regardless of the presence of genomic aberrations.