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Association details:
| Biomarker: | Chr del(11q) |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Calquence (acalabrutinib) (BTK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Calquence met primary efficacy endpoint in head-to-head trial against ibrutinib in chronic lymphocytic leukaemia
Published date:
01/25/2021
Excerpt:
CLL with high-risk features (presence of 17p deletion and/or 11q deletion)...Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib.
Trial ID:
Source:
Title:
Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients
Excerpt:
...Fluorescence in situ hybridization (FISH) for which the next-generation sequencing (NGS) method is preferred) within 60 days during screening up to before the first dose reflecting the presence or absence of del(17p), 13q del, 11q del, and trisomy of chromosome 12 along with the percentage of cells with the deletion, along with TP53 sequencing....
Trial ID:
Source:
Title:
033 | FIRST RESULTS OF A HEAD-TO-HEAD TRIAL OF ACALABRUTINIB VERSUS IBRUTINIB IN PREVIOUSLY TREATED CHRONIC LYMPHOCYTIC LEUKEMIA
Published date:
06/09/2021
Excerpt:
533 pts (Aca, n = 268; Ib, n = 265) were randomized (median age 66 y; median 2 prior therapies; del(17p) 45.2%; del(11q) 64.2%). At median follow-up of 40.9 mo (range 0.0–59.1), Aca was noninferior to Ib with median PFS of 38.4 mo in both arms (HR 1.00; 95% CI 0.79–1.27).
