Zanubrutinib as frontline option regardless of del(17p) and/or X3Zjmut status
Updates on zanubrutinib monotherapy in high-risk, treatment-naïve (TN) CLL from the SEQUOIA study.]f[
These long-term results continue to support zanubrutinib as an effective, tolerable frontline option for CLL, including in those with high-risk features.]f[
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Long-term extension from the Phase 3 ALPINE study continues to demonstrate sustained PFS benefit and response rates regardless of del(17p) status.Q
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Updated safety and efficacy data from the ongoing Phase 1/2 CaDAnCe-101 study in high-risk patients resistant to BTK and BCL2 inhibitors.@
The CaDAnCe-101 study demonstrated antitumor activity, including in patients with BTKi-resistance mutations and those previously exposed to cBTK, ncBTK, and BCL2 inhibitors.@
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Updated data from the ongoing Phase 1/1b study BGB-11417-101, regardless of risk factors.aDQ
The currently recruiting Phase 3 CELESTIAL-RRCLL trial will further assess the sonrotoclax + obinutuzumab combo in patients with R/R CLL.i
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Results from the ongoing Phase 1/1b study BGB-11417-101, in patients with R/R mantle cell lymphoma (MCL).j
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| #XV adverse events; D)/{m adverse events of special interest; sIrY alanine aminotransferase; $R%/ aspartate aminotransferase; ]O4v twice daily; %F0pmG B-cell lymphoma 2 inhibitor; t~D!:3 covalent Bruton tyrosine kinase inhibitor; q\{ confidence interval; 4JJJ chronic lymphocytic leukemia; :qq complete response; 9pAh complete response with incomplete marrow recovery; V1We duration of response; &i8 hazard ratio; TBsx| immunoglobulin heavy chain; =E^U mantle cell lymphoma; a%q1 minimal residual disease; MRD@+: <10-4 CLL cells of total WBCs; MRDw: <10-5 CLL cells of total WBCs; =aC3 maximum tolerated dose; I}QksT? noncovalent Bruton tyrosine kinase inhibitor; :ll^ objective response rate; |
LJO overall survival; Q$4 progressive disease; By8 pharmacokinetic; mEf partial response; vE6BC patient-reported outcomes; DkC once daily; K3G3 progression-free survival; x8xd relapsed/refractory; &F2I@ recommended dose for expansion; ]en;e recommended Phase 2 dose; y5p stable disease; 1iiI small lymphocytic lymphoma; J*Y*}& treatment-emergent adverse events; !s6W tumour lysis syndrome; oDe treatment naive; iiiiT time to next treatment; &+7lH undetectable measurable residual disease; uMRDi: <10-6 CLL cells of total WBCs; ucP?| white blood cells. |
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@. Tam, C.S., /r 68. Sustained Efficacy of Zanubrutinib vs Bendamustine + Rituximab in Treatment-Naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Continued Favorable Survival in Non-randomized Patients With del(17p): 6-Year Follow-Up in the Phase 3 SEQUOIA Study. Poster Presentation 2129 at the ASH Annual Meeting and Exposition; 6-9 December 2025; Orlando, USA.
). Shadman, M., /r 68. Zanubrutinib + Venetoclax for Treatment-Naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Including Patients With del(17p) and/or TP53 Mutation and Unmutated Immunoglobulin Heavy-Chain Variable Status: 3-Year Results From SEQUOIA Arm D. Poster Presentation 5669 at the ASH Annual Meeting and Exposition; 6-9 December 2025; Orlando, USA.
Z. Tam, C.S., /r 68. Long-Term Results of Patients Receiving Zanubrutinib in the Phase 3 ALPINE Study Confirm Sustained Benefit of Zanubrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma: Up to 6 Years of Follow-Up With the Long-Term Extension. Poster Presentation 2123 at the ASH Annual Meeting and Exposition; 6-9 December 2025; Orlando, USA.
k. Ahn, I.E., /r 68. Updated Efficacy and Safety Results of the Bruton Tyrosine Kinase DeGrader BGB-16673 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma From the Ongoing Phase 1 CaDAnCe-101 Study. Presentation at the ASH Annual Meeting and Exposition; 6-9 December 2025; Orlando, USA.
t. Tam, C.S., /r 68. Frontline Treatment of Sonrotoclax (BGB-11417) + Zanubrutinib for CLL/SLL Demonstrates High uMRD Rates With Favorable Tolerability: Updated Data From BGB-11417-101, An Ongoing Phase 1/1b Study. Poster Presentation 3891 at the ASH Annual Meeting and Exposition; 6-9 December 2025; Orlando, USA.
(. Hoffmann, M.S., /r 68. MRD-Guided Therapy of Sonrotoclax (BGB-11417) + Obinutuzumab in Patients With Treatment-Naive CLL: Initial Results From an Ongoing Phase 1/1b Study, BGB-11417-101. Presentation at the ASH Annual Meeting and Exposition; 6-9 December 2025; Orlando, USA.
f. Wang, M., /r 68. Sonrotoclax (BGB-11417) Monotherapy in Patients With R/R MCL Previously Treated With a BTK Inhibitor: Results From a Phase 1/2 Study. Presentation at the ASH Annual Meeting and Exposition; 6-9 December 2025; Orlando, USA.



