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    Association details:
    Biomarker:No biomarker
    Cancer:Chronic Lymphocytic Leukemia
    Drug:Gazyva (obinutuzumab) (CD20 inhibitor) +
    Calquence (acalabrutinib) (BTK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Scottish Medicines Consortium
    Title:

    acalabrutinib (Calquence) is accepted for restricted use within NHSScotland

    Published date:
    03/05/2021
    Excerpt:
    acalabrutinib (Calquence) is accepted for restricted use within NHSScotland....as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    11/05/2020
    Excerpt:
    Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    The panel consensus was to include acalabrutinib+/- obinutuzumab with a category 2A recommendation for all patients with CLL...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    PPLC 2021
    Title:

    Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in TreatmentNaïve Chronic Lymphocytic Leukemia: ELEVATE-TN 4-Year Follow-up

    Published date:
    08/09/2021
    Excerpt:
    A 4-year update analysis from the phase 3 ELEVATE-TN study was performed to assess long-term efficacy and safety of acalabrutinib (A) ± obinutuzumab (O)...Median PFS was significantly longer for A-containing arms...A+O vs O+Clb: HR 0.10 (95% CI: 0.07, 0.17)...A vs O+Clb: HR 0.19 (95% CI: 0.13, 0.28)...A ± O demonstrates durable disease control, tolerability, and flexibility to tailor treatment as a monotherapy or combination therapy in TN CLL patients.
    Trial ID:
    ELEVATE-TN
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    AstraZeneca Press Release
    Title:

    Calquence granted US Breakthrough Therapy Designation for chronic lymphocytic leukaemia

    Published date:
    08/14/2019
    Excerpt:
    AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL)...The FDA granted the BTD based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials.
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    Blood
    Title:

    ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL)

    Excerpt:
    Acalabrutinib + O and acalabrutinib monotherapy significantly improved PFS vs O + Clb, with tolerable safety in pts with TN CLL.
    DOI:
    10.1182/blood-2019-128404
    Trial ID:
    ELEVATE-TN
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    Lancet
    Title:

    Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial

    Excerpt:
    We compare the efficacy of acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab in patients with treatment-naive chronic lymphocytic leukaemia....At median follow-up of 28·3 months (IQR 25·6-33·1), median progression-free survival was longer with acalabrutinib-obinutuzumab and acalabrutinib monotherapy,…
    DOI:
    10.1016/S0140-6736(20)30262-3
    Trial ID:
    ELEVATE-TN