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Association details:
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
12/03/2020
Excerpt:
Suggested treatment regimens...CLL/SLL with del(17p)/TP53 mutation…First-line therapy…other recommended regimens...Zanubrutinib (for patients with contraindication to other BTKi)
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Zanubrutinib vs bendamustine + rituximab (BR) in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma: extended follow-up of the SEQUOIA study

Published date:
10/06/2023
Excerpt:
For 110 patients with del(17p) assigned to zanubrutinib monotherapy, after a median follow-up of 47.9 months, the estimated 42-month PFS and OS rates were 79.4 and 89.5%, respectively.
DOI:
https://doi.org/10.1080/10428194.2023.2250219
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

First Interim Analysis of ALPINE Study: Results of a Phase 3 Randomized Study of Zanubrutinib vs Ibrutinib in Patients With Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (CLL/SLL)

Published date:
09/21/2022
Excerpt:
ALPINE (NCT03734016) is a global, randomized, phase 3 study of zanubrutinib versus ibrutinib in patients with R/R CLL/SLL...ORR was higher for zanubrutinib in patients with del(11)q (83.6% vs 69.1%) and del(17)p (83.3% vs 53.8%)…
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

CLL-115 First Interim Analysis of ALPINE Study: Results of a Phase 3 Randomized Study of Zanubrutinib vs Ibrutinib in Patients With Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Published date:
09/21/2022
Excerpt:
...ORR was higher for zanubrutinib in patients with del(11)q (83.6% vs 69.1%) and del(17)p (83.3% vs 53.8%); zanubrutinib had higher overall 12-month progression-free survival (PFS; 94.9% vs 84.0%) and overall survival (97.0% vs 92.7%)...In summary, this interim analysis showed zanubrutinib had a superior ORR, improved PFS, and lower AF rate compared to ibrutinib.
DOI:
https://doi.org/10.1016/S2152-2650(22)01324-6
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

FIRST INTERIM ANALYSIS OF ALPINE STUDY: RESULTS OF A PHASE 3 RANDOMIZED STUDY OF ZANUBRUTINIB VS IBRUTINIB IN PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA

Published date:
05/12/2021
Excerpt:
ORR was higher in patients with del11q (83.6% vs 69.1%) and del17p (83.3% vs 53.8%) with zanubrutinib, as were overall 12-mo PFS (94.9% vs 84.0%, Figure) and OS rates (97.0% vs 92.7%)
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Efficacy and Safety of Zanubrutinib in Patients with Treatment-Naive Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with Del(17p): Initial Results from Arm C of the Sequoia (BGB-3111-304) Trial

Published date:
11/06/2019
Excerpt:
The SEQUOIA trial is an open-label, global, multicenter, phase 3 study that includes a non-randomized cohort (Arm C) of TN patients with del(17p) CLL/SLL treated with zanubrutinib (160 mg twice daily)….The overall response rate was 92.2%...No patient had progressed with CLL/SLL.
DOI:
https://doi.org/10.1182/blood-2019-125394
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Efficacy and Safety of Zanubrutinib in Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with del(17p): Follow-up Results from Arm C of the SEQUOIA (BGB-3111-304) Trial

Excerpt:
Extended follow-up of zanubrutinib monotherapy in TN CLL/SLL pts with del(17p) showed the durability of responses in this high-risk cohort, with an estimated 18-mo PFS of 88.6% and estimated 18-mo OS of 95.1%. Zanubrutinib was generally well tolerated, with low rates of discontinuation due to AEs. These data support the potential utility of zanubrutinib in the frontline management of pts with high-risk disease.
DOI:
https://doi.org/10.1182/blood-2020-134280
Trial ID: