R/R CLL: phase 3 PRO data for ibrutinib vs ofatumumab

  • Barrientos JC & al.
  • Clin Lymphoma Myeloma Leuk
  • 18 Aug 2018

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In the phase 3 RESONATE study, patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) receiving ibrutinib experienced notable improvements in hematologic function and disease-related symptoms vs those receiving ofatumumab.

Why this matters

  • According to patient-reported outcomes (PRO), the emotional well-being of patients with CLL is generally lower than that reported by patients with other malignancies.

Study design

  • Analysis of PRO parameters in the RESONATE study of 391 patients with R/R CLL/SLL receiving ibrutinib (n=195) or ofatumumab (n=196).
  • Median number of prior therapies:
    • Ibrutinib group: 3 (range, 1-12).
    • Ofatumumab group: 2 (range, 1-13).
  • Funding: Pharmacyclics LLC, an AbbVie Company.

Key results

  • Significantly greater proportion of patients with sustained hematologic improvement with ibrutinib vs with ofatumumab:
    • Improved platelets: 82% vs 22% (P<.0001>
    • Improved neutrophils: 68% vs 32% (P=.011).
    • Improved hemoglobin: 69% vs 37% (P<.0001>
    • Improvement in any cytopenia: 79% vs 43% (P<.0001>
  • Greater proportion of patients with improvement in disease-related symptoms with ibrutinib vs with ofatumumab:
    • Weight loss: 100% vs 87%.
    • Fatigue: 79% vs 64%.
    • Night sweats: 89% vs 77%.
    • Abdominal pain/discomfort: 96% vs 75%.
    • Anorexia: 100% vs 64%.

Limitations

  • Patient-reported data.

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