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Association details:
| Biomarker: | Chr del(11q) |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Brukinsa (zanubrutinib) (BTK inhibitor) |
| Direction: | Sensitive |
Evidence:
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 (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:
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:
