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Association details:
| Biomarker: | Chr del(17p) |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Brukinsa (zanubrutinib) (BTK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
BRUKINSA® Receives Positive Recommendation from NICE in U.K. for Adult Patients with Chronic Lymphocytic Leukemia
Published date:
10/20/2023
Excerpt:
BeiGene, Ltd...announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a final draft guidance (FDG) recommending BRUKINSA® (zanubrutinib) for the treatment of eligible adult patients with...Untreated chronic lymphocytic leukemia (CLL) if there is a 17p deletion or TP53 mutation (high risk) or...Relapsed or refractory CLL.
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).
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:
Source:
Title:
IMPROVED EFFICACY AND SAFETY OF ZANUBRUTINIB VERSUS IBRUTINIB IN PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (R/R CLL) IN CHINA: A SUBGROUP OF ALPINE
Published date:
06/09/2023
Excerpt:
Additionally, zanubrutinib was more favorable in high-risk del17p/TP53 mutation (18-mo landmark 80.0% vs. 64.3%; HR: 0.51; 95% CI 0.12-2.13). ORR also favored zanubrutinib over ibrutinib (87.2% vs. 76.7%; 95% CI 0.93-1.38) by IRC.
DOI:
https://doi.org/10.1002/hon.3165_592
Trial ID:
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:
Source:
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:
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:
Source:
Title:
ZANUBRUTINIB MONOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA: 34-MONTH FOLLOW-UP RESULTS
Published date:
05/12/2021
Excerpt:
...patients with R/R CLL/SLL received oral zanubrutinib...Patients with del(17p) and/or TP53 mutation and del(11q) achieved high response rates of 91% (95% CI, 70.8%>98.9%) and 100% (95% CI, 83.2%>100%), respectively….Deep and durable responses were achieved in all patient subgroups including patients with high-risk cytogenetics. Data support the tolerability of long-term zanubrutinib treatment in R/R CLL/SLL, with no new safety signals identified.
Trial ID:
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:
At data cutoff, 90 patients were evaluable for efficacy with median follow-up of 7.0 mo; of these, 87 patients remained on study treatment. The overall response rate was 92.2% (Table 2).
DOI:
10.1182/blood-2019-125394
Source:
Title:
Treatment with the Bruton Tyrosine Kinase Inhibitor Zanubrutinib (BGB-3111) Demonstrates High Overall Response Rate and Durable Responses in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): Updated Results from a Phase 1/2 Trial
Published date:
11/06/2019
Excerpt:
...117 patients with CLL and 5 patients with SLL had received zanubrutinib (Table 1)…For patients with del(17p), ORR was 94% and CRR was 6%; PFS rate at 2 years was 75%.
DOI:
https://doi.org/10.1182/blood-2019-125483
Source:
Title:
Zanubrutinib monotherapy for patients with treatment naïve chronic lymphocytic leukemia and 17p deletion
Excerpt:
The overall response rate was 94.5% with 3.7% of patients achieving complete response with or without incomplete hematologic recovery. The estimated 18-month progression-free survival rate was 88.6% (95% CI, 79.0 – 94.0) and the estimated 18-month overall survival rate was 95.1% (95% CI, 88.4 – 98.0)....Zanubrutinib was active and well tolerated in this large, prospectively enrolled treatment cohort of previously untreated patients with del(17p) chronic lymphocytic leukemia/small lymphocytic lymphoma.
DOI:
https://doi.org/10.3324/haematol.2020.259432
Trial ID:
