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A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Trial Profile

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2026

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At a glance

  • Drugs Pirtobrutinib (Primary) ; Ibrutinib
  • Indications Chronic lymphocytic leukaemia
  • Focus Expanded access; Registrational; Therapeutic Use
  • Acronyms BRUIN-CLL-314
  • Sponsors Loxo Oncology

Most Recent Events

  • 07 Dec 2025 According to an Eli Lilly and Company media release, a formal progression-free survival (PFS) analysis to test for superiority is planned for a future analysis.
  • 07 Dec 2025 According to an Eli Lilly and Company media release, data from the trial will be published in the Journal of Clinical Oncology and featured as part of the meeting's press program.
  • 07 Dec 2025 According to an Eli Lilly and Company media release, progression-free survival data were immature but favored pirtobrutinib, showing a 43% reduction in the risk of disease progression or death in the ITT population; the treatment-naive subgroup, which had the longest follow-up, demonstrated a 76% risk reduction.

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