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    Association details:
    Biomarker:TP53 deletion
    Cancer:Chronic Lymphocytic Leukemia
    Drug:Imbruvica (ibrutinib) (BTK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    ESMO.org
    Title:

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

    Excerpt:
    ...it is recommended that patients with TP53 deletion/mutation are treated with novel inhibitors (ibrutinib; idelalisib and rituximab) in front-line and relapse settings.
    DOI:
    10.1093/annonc/mdv303
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    Am J Hematol
    Title:

    Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma

    Excerpt:
    The PFS benefit with ibrutinib vs ofatumumab was preserved in the genomic high‐risk population with del(17p), TP53 mutation, del(11q), and/or unmutated IGHV status (median PFS 44.1 vs 8.0 months; HR: 0.110; 95% CI: 0.080‐0.152), which represented 82% of patients. Overall response rate with ibrutinib was 91%...study showed improved efficacy of single‐agent ibrutinib over ofatumumab in patients with relapsed/refractory CLL/SLL...
    DOI:
    10.1002/ajh.25638
    Trial ID:
    RESONATE Study
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    therapy with ibrutinib for patients with Chronic lymphocytic leukemia with subclonal TP53 aberrations terapia con Ibrutinib per pazienti affetti da leucemia linfatica cronica che presentano alterazioni subclonali di TP53

    Excerpt:
    ...Cohort 2 only: Evidence of a small (<20%) subclone carrying TP53 deletion by FISH 1. ...
    Trial ID:
    2017-001099-49
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    N Engl J Med
    Title:

    Ibrutinib for Chronic Lymphocytic Leukemia with TP53 Alterations

    Excerpt:
    34 patients who had CLL with TP53 alterations were treated with ibrutinib as first-line therapy...As the best response, 30% had a complete response to treatment...At 6 years, the estimated percentage of patients with progression-free survival and overall survival was 61% and 79%, respectively...The data that are summarized here underscore the longer durability of response with ibrutinib than with chemoimmunotherapy
    DOI:
    10.1056/NEJMc2005943
    Trial ID:
    NCT01500733