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Area of interest

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December 6-9, 2025 Orlando, United States
Area of interest

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

With up to 6 years of follow-up, patients with del(17p) treated with zanubrutinib demonstrated sustained efficacy comparable with the overall population, along with a similar safety profile.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

These preliminary data highlight the potential for the all-oral therapy sonrotoclax + zanubrutinib combination. The currently enrolling Phase 3 CELESTIAL-TNCLL trial will provide further evidence in patients with TN CLL.w

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

Sonrotoclax monotherapy was well tolerated and demonstrated clinically meaningful benefits in heavily pretreated patients with advanced 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.

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