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An expert panel hosted by
Customizing first-line BTK inhibitors for CLL
with Gilles Salles, Paolo Ghia, and Francesc Bosch
Wednesday, October 23, 2024
18:30-19:30 BST
This independent educational activity is supported by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech. All content is developed independently by the faculty. The funder is allowed no influence on the content of this activity.
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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 |
Key learnings: |
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%). |
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). |
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). |
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). |
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%). |
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.
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