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Zanubrutinib vs ibrutinib for R/R CLL/SLL: Final comparative analysis results from the ALPINE trial
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Final comparative analysis results from the ALPINE trial (NCT03734016), a phase III study that evaluated the efficacy and safety of zanubrutinib vs ibrutinib in patients with R/R CLL, have been published in Blood by Brown et al.1 Overall, 652 patients received zanubrutinib (n = 327) or ibrutinib (n = 325). The primary endpoints were ORR, CR/CRi, PR, or nPR, and key secondary endpoints included PFS, rate of AF/flutter, OS, and safety.1 |
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After a median follow-up of 42.5 months, ORR and CR rates were higher following treatment with zanubrutinib vs ibrutinib (ORR, 85.6% vs 75.4%; CR/CRi rate, 11.6% vs 7.7%). |
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PFS survival benefits were sustained in the zanubrutinib arm vs ibrutinib arm (HR, 0.68; 95% CI, 0.54-0.84), including in patients with del(17p)/TP53 mutation (HR, 0.51; 95% CI, 0.33-0.78). |
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The median OS was not reached in either arm; fewer patients died in the zanubrutinib arm vs ibrutinib arm (HR, 0.77; 95% CI, 0.55-1.06). |
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There were fewer cardiac events, AF, and CV deaths with zanubrutinib (25.9%, 7.1%, and 0, respectively) vs with ibrutinib (35.5%, 17.0%, and 6, respectively). |
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The most common non-hematologic AEs in the zanubrutinib and ibrutinib arms included COVID-19-related infection (46.0% vs 33.3%), diarrhea (18.8% vs 25.6%), upper RTI (29.3% vs 19.8%), and hypertension (27.2% vs 25.3%). |
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The efficacy and tolerable safety data from the phase III ALPINE trial supports the use of zanubrutinib over ibrutinib for the treatment of patients with R/R CLL/SLL. |
Abbreviations: AE, adverse event; AF, atrial fibrillation; CLL, chronic lymphocytic leukemia; CI, confidence interval; CR, complete response; CR/CRi, CR with incomplete count recovery; CV, cardiovascular; HR, hazards ratio; ORR, overall response rate; OS, overall survival; PR, partial response; nPR, nodular PR; R/R relapsed and refractory; RTI, respiratory tract infection; SLL, small lymphocytic lymphoma.
References
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