ASH 2018 — Ibrutinib/rituximab tops FCR for PFS, OS in untreated CLL


  • Wayne Kuznar
  • Univadis
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Takeaway

  • Ibrutinib+rituximab extends PFS and OS relative to the current standard of care in patients aged ≤70 years with previously untreated CLL.

Why this matters

  • Study establishes ibrutinib+rituximab as superior to the standard fludarabine+cyclophosphamide+rituximab (FCR).

Study design

  • Phase 3 E1912 study of 529 treatment-naive patients aged 28-70 (median, 58) years with CLL randomly assigned 2:1 to ibrutinib+rituximab or FCR.
  • Median follow-up, 33.4 months.
  • Funding: National Cancer Institute; Pharmacyclics LLC

Key results

  • Ibrutinib+rituximab extended PFS vs FCR (HR, 0.352; P<.00001>
  • Ibrutinib+rituximab extended PFS vs FCR (HR, 0.168; P<.0003>
  • Ibrutinib+rituximab benefit was independent of age, sex, performance status, disease stage, or the presence/absence of del11q23. 
  • Ibrutinib+rituximab was superior to FCR for PFS in patients with unmutated IGHV (HR, 0.262; P<.0001 but not mutated ighv p=".07).</li">
  • Rates of any grade ≥3 adverse events were lower with ibrutinib+rituximab vs FCR (58.5% vs 72.1%; P=.0004).
  • Specifically, rates of grade 3-4 neutropenia, anemia, thrombocytopenia, and any infection were lower with ibrutinib+rituximab vs FCR (all P<.001>

Limitations

  • Patients with deletion 17p excluded.
  • Further monitoring needed to determine durability of responses.