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. 2023 Dec 29;16(1):55. doi: 10.3390/pharmaceutics16010055

Table 7.

Zanubrutinib clinical studies in patients with CLL or SLL.

Clinical Study Type of Study Eligible Patients Treatment Endpoints Conclusion Ref.
SEQUOIA Phase III, open-label, multicenter study Previously untreated CLL or SLL
≥65 or ≥18 years
ECOG 0 -2
Zanubrutinib vs. BR PFS Zanubrutinib showed a notable improvement in PFS and safety profile compared to BR accompanied. These results lend support to zanubrutinib as a potential treatment option for untreated CLL and SLL. [128]
ALPINE Head-to-head Phase III study r/r CLL/SLL patients Zanubrutinib vs. ibrutinib ORR
PFS
OS
Zanubrutinib demonstrated superiority over ibrutinib in terms of PFS, OS, and safety profile. In patients with del17p, TP53mut, or both, those treated with zanubrutinib experienced PFS compared with ibrutinib. [129]
NCT03206918 Phase II, single-arm, multicenter study r/r CLL/SLL patients Zanubrutinib ORR
PFS
Results showed that administering zanubrutinib twice daily led to a significant occurrence of lasting responses. Zanubrutinib presents the possibility of enhanced safety and tolerability compared to current treatment choices. [130]