DLBCL: phase 3 results for frontline ibrutinib plus R-CHOP

  • Younes A & al.
  • J Clin Oncol
  • 22 Mar 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In previously untreated nongerminal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), the addition of ibrutinib to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) delivered numerical but not statistically significant improvements in survival outcomes among younger patients.

Why this matters

  • No novel therapy has succeeded in outperforming R-CHOP in this setting in the last 2 decades.

Study design

  • Phase 3 study to investigate ibrutinib combined with R-CHOP in 838 patients with previously untreated non-GCB DLBCL.
  • 419 patients received ibrutinib+R-CHOP; 419 received placebo+R-CHOP.
  • Median patient age: 62.0 years.
  • Funding: Janssen Global Services; Memorial Sloan Kettering Cancer Center.

Key results

  • The addition of ibrutinib delivered no significant improvement in:
    • Event-free survival (EFS) in the intent-to-treat population (ITT; P=.5906).
    • EFS in patients with ABC subtype disease (P=.7311).
    • PFS (P=.5027).
    • OS (P=.9593).
  • In a post hoc analysis of patients aged
  • EFS: HR, 0.579; 95% CI, 0.380-0.881.
  • PFS: HR, 0.556; 95% CI, 0.359-0.860.
  • OS: HR, 0.330; 95% CI, 0.162-0.673.
  • 35.1% of patients aged ≥60 years and 15.0% of patients aged

    Limitations

    • Enrollment bias toward fit study population.
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