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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Published date:
03/05/2021
Excerpt:
acalabrutinib (Calquence) is accepted for restricted use within NHSScotland....as monotherapy for the treatment of adult patients with previously untreated CLL who have a 17p deletion or TP53 mutation and in whom chemoimmunotherapy is unsuitable.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Chemotherapy-free treatment option to be offered to patients with England’s most common leukaemia

Published date:
03/18/2021
Excerpt:
Acalabrutinib, taken as a twice daily tablet, is recommended as an option for adults with untreated chronic lymphocytic leukaemia (CLL)...NICE has recommended the use of acalabrutinib, as a monotherapy option for adults with...a 17p deletion...
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Title:

Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Excerpt:
Recommendations: TP53 mutation or del(17p): ibrutinib or acalabrutinib or venetoclax plus obinutuzumab or venetoclax alone or idelalisib plus rituximab [III, A].
DOI:
10.1016/j.annonc.2020.09.019
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Suggested treatment regimens...CLL/SLL with del(17p)/TP53 mutation…first line therapy…preferred regimen...Acalabrutinib ± obinutuzumab
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Three-Year Follow-up of the Ascend Trial: Acalabrutinib Vs Rituximab Plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia

Published date:
11/04/2021
Excerpt:
In this randomized, multicenter, open-label, phase 3 study (NCT02970318), patients with R/R CLL were randomized 1:1 to receive acala 100 mg orally (PO) twice daily or investigator’s (INV) choice of IdR (Id: 150 mg PO twice daily; R: 375 x1 then 500 mg/m2 intravenously [IV] for 8 total infusions) or BR (B: 70 mg/m2 IV and R: 375 x1 then 500 mg/m2 IV for 6 total cycles)...in patients with the del(17p) mutation...36-month PFS rates were 66% and 5% for acala and IdR/BR, respectively. At 3 years of follow-up, the efficacy of acala monotherapy was maintained, showing a significant PFS benefit over standard-of-care regimens in patients with R/R CLL.
DOI:
10.1182/blood-2021-146570
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

CLL-139: Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-Naïve Chronic Lymphocytic Leukemia: ELEVATE-TN 4-Year Follow-up

Published date:
09/01/2021
Excerpt:
In patients with del(17p) and/or TP53, median PFS was NR (A+O and A) vs 17.5 months for O+Clb (P<0.0001).
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
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).
Evidence Level:
Sensitive: B - Late Trials
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:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia

Excerpt:
Eligible patients, aged ≥ 18 years with R/R CLL, were randomly assigned 1:1 centrally and stratified by del(17p) status…a total of 398 patients were assessed for eligibility; 310 patients were randomly assigned to acalabrutinib monotherapy (n = 155) or investigator’s choice (n = 155; I-R, n = 119; B-R, n = 36). Patients had received a median of two prior therapies (range, 1-10). After a median follow-up of 16.1 months (range, 0.03-22.4 months), median PFS was significantly longer with acalabrutinib monotherapy (PFS not reached) compared with investigator’s choice (16.5 months [95% CI, 14.0 to 17.1 months]; hazard ratio, 0.31 [95% CI, 0.20 to 0.49]; P < .0001). Estimated 12-month PFS was 88% (95% CI, 81% to 92%) for acalabrutinib and 68% (95% CI, 59% to 75%) for investigator’s choice....Acalabrutinib significantly improved PFS compared with I-R or B-R and has an acceptable safety profile in patients with R/R CLL.
DOI:
10.1200/JCO.19.03355
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

LONG-TERM EFFICACY OF ACALABRUTINIB-BASED REGIMENS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND HIGHER-RISK GENOMIC FEATURES: POOLED ANALYSIS OF CLINICAL TRIAL DATA

Published date:
05/12/2022
Excerpt:
Data were pooled from CLL pts with higher-risk genomic features treated with A ± obinutuzumab (O) in 3 clinical studies...At 47.3 mo median follow-up (range 1.0–82.0), median PFS was not reached (NR) in TN pts with del(17p)/TP53m with A-based regimens; PFS rates at 48 mo suggest similar efficacy with A and A+O in TN pts with del(17p)/TP53m (76% and 77%, respectively) (Fig 1A)....In this pooled analysis of clinical trial data in 801 CLL pts with higher-risk genomic features, efficacy of A-based regimens led to high PFS and OS rates at a median follow-up of nearly 4 y.