Frontline ibrutinib-rituximab tops chemoimmunotherapy for CLL

  • Shanafelt TD & al.
  • N Engl J Med
  • 1 Aug 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In patients aged ≤70 years with previously untreated chronic lymphocytic leukemia (CLL), a regimen of ibrutinib+rituximab demonstrated superior survival outcomes vs standard chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR).

Why this matters

  • FCR is the standard frontline approach in this setting.

Study design

  • Phase 3 study to compare 1 cycle of ibrutinib followed by 6 cycles of ibrutinib+rituximab then ibrutinib until disease progression (n=354) vs 6 cycles of chemoimmunotherapy with FCR (n=175) in 529 patients aged ≤70 years with previously untreated CLL.
  • Funding: National Cancer Institute of the National Institutes of Health; Pharmacyclics.

Key results

  • 89.4% (95% CI, 86.0%-93.0%) PFS at 3 years with ibrutinib+rituximab vs 72.9% (95% CI, 65.3%-81.3%) with chemoimmunotherapy.
    • HR for progression or death=0.35; 95% CI, 0.22-0.56; P<.001.>
  • 98.8% (95% CI, 97.6%-100%) OS at 3 years with ibrutinib+rituximab vs 91.5% (95% CI, 86.2%-97.0%) with chemoimmunotherapy.
    • HR for death=0.17; 95% CI, 0.05-0.54; P<.001.>
  • 80.1% of patients receiving ibrutinib+rituximab experienced a grade ≥3 adverse event vs 79.7% with chemoimmunotherapy.

Limitations

  • OS findings were based on a limited number of events.