New Reference: Pirtobrutinib for BTKi Pretreated CLL

  • Study

    Open-label, randomized, phase III study [BRUIN CLL-321]
    Relapsed/refractory CLL/SLL, previously treated with BTKi
    Pirtobrutinib (n=119) vs investigator’s choice of Idelalisib/Rituximab or Bendamustine/Rituximab (n=119)

  • Efficacy

    ORR: 69% vs 50%
    mPFS: 14 mos vs 8.7 mos (HR 0.54 [0.39-0.75])
    18-mo OS rate: 73.4% vs 70.8%
    Median TTNT: 24 mos vs 10.9 mos (HR 0.37 [0.25-0.52])

  • Safety

    Grade >=3 AE: 57.7% vs 73.4%
    Treatment discontinuations due to AE: 17.2% vs 34.9%


    • J Clin Oncol 2025;43:2538-2549

    Sharman JP,Munir T,Grosicki S Phase III Trial of Pirtobrutinib Versus Idelalisib/Rituximab or Bendamustine/Rituximab in Covalent Bruton Tyrosine Kinase Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

    http://doi.org/10.1200/JCO-25-00166

    Reviewed by Elvin Chalabiyev, MD on Sep 3, 2025

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