Mantle cell lymphoma

New Indication: Ibrutinib with Venetoclax for Mantle Cell Lymphoma

2025-03-02

  • Study

    Randomised, double-blind, placebo-controlled phase 3 trial (SYMPATICO)
    Relapsed or refractory mantle cell lymphoma (MCL) after 1-5 prior therapies
    Ibrutinib 560 mg daily + Venetoclax ramp-up to 400 mg daily vs. Ibrutinib 560 mg daily + placebo

  • Efficacy

    mPFS: 31.9 mos vs. 22.1 mos (ibrutinib-venetoclax vs. ibrutinib-placebo) (HR:0.65 [0.47-0.88])
    24-mo PFS: 66% vs. 61%
    mOS: NR vs. 15.4 mos in TP53-mutated patients

  • Safety

    Grade ≥3 AEs: neutropenia (31% vs. 11%), thrombocytopenia (13% vs. 8%), pneumonia (12% vs. 11%)
    Serious AEs: 60% vs. 60%
    Treatment-related deaths: 2% vs. 2% (COVID-19, cardiac arrest, respiratory failure, pneumonia)


    • Lancet Oncol 2025;26:200-13

    Wang M,Jurczak W,Trneny M Ibrutinib plus venetoclax in relapsed or refractory mantle cell lymphoma (SYMPATICO): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study

    http://doi.org/10.1016/S1470-2045(24)00048-7

    Reviewed by Ulas D. Bayraktar, MD on Mar 2, 2025