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    Association details:
    Biomarker:TP53 mutation
    Cancer:Chronic Lymphocytic Leukemia
    Drug:Calquence (acalabrutinib) (BTK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Scottish Medicines Consortium
    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:
    NICE
    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...TP53 mutation...
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Suggested treatment regimens...CLL/SLL with del(17p)/TP53 mutation…first line therapy…preferred regimen...Acalabrutinib ± obinutuzumab
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    ESMO.org
    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: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)

    Excerpt:
    ...after 1-4 therapy lines if del 17 or p53 mutation in >10% of analyzed CLL cells (PB or BM) or 2....
    Trial ID:
    ACALLO
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL

    Excerpt:
    ...- Relapsed/Refractory CLL or treatment naïve CLL patients with 17p deletion, TP53 mutation, or NOTCH1 mutation...
    Trial ID:
    15-H-0016
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Early Intervention With Acalabrutinib in Patients With High Risk CLL

    Excerpt:
    ...- Deletion 17p, or presence of TP53 mutation...
    Trial ID:
    NCT04660045
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Acalabrutinib in CLL and MCL patients subjected to allogeneic hematopoietic stem cell transplantation (alloSCT). Zastosowanie akalabrutynibu u chorych z przewlekłą białaczką limfocytową lub chłoniakiem z komórek płaszcza poddanych allogenicznemu przeszczepieniu komórek macierzystych.

    Excerpt:
    ...after 1-4 therapy lines if del 17 or p53 mutation in >10% of analyzed CLL cells (PB or BM) orb. ...
    Trial ID:
    2018-003465-33
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia

    Excerpt:
    ......
    Trial ID:
    STAIR
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EHA 2022
    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.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2019
    Title:

    Preliminary Safety and Efficacy Results from a Phase 2 Study of Acalabrutinib, Venetoclax and Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL)

    Published date:
    11/06/2019
    Excerpt:
    Our preliminary data suggest that even at an early response evaluation after 8 cycles of therapy (including only 4 months of V), AVO as frontline CLL therapy leads to a high proportion of pts achieving BM-uMRD and CR, including pts with TP53-aberrant disease. The AE profile is favorable, with a low rate of infusion reactions and no significant cardiac or bleeding toxicities. Updated data will be presented at the meeting for this ongoing study. Based on our initial results we have opened an expansion cohort to further characterize the efficacy and safety of AVO.
    DOI:
    10.1182/blood-2019-127506
    Trial ID:
    NCT03580928