R/R CLL: ibrutinib yields sustained PFS benefit in RESONATE

  • Byrd JC & al.
  • Blood
  • 6 Mar 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), extended treatment with ibrutinib sustained long-term PFS benefits, even despite higher-risk cytogenetics.  

Why this matters

  • Durable remissions in this setting are possible with fludarabine, cyclophosphamide, and rituximab (FCR); however, many patients are FCR-unfit.  

Study design

  • Long-term follow-up of the phase 3 RESONATE study to investigate single-agent ibrutinib (n=195) vs single-agent ofatumumab (n=196) in patients with R/R CLL.
  • Funding: Pharmacyclics LLC and Janssen Pharmaceuticals.

Key results

  • 44 (range: 0.33-53.16) months median follow-up.
  • Median PFS was not reached (NR) with ibrutinib vs 8.1 months with ofatumumab: HR=0.133; 95% CI, 0.099-0.178; P<.0001.>
  • Median PFS NR in patients with ≤2 lines of prior therapy vs 35.1 months in patients with >2 prior lines.
  • PFS benefits extended across all studied subgroups including del(17)p disease (HR=0.125; 95% CI, 0.074-0.210) and TP53 mutated disease (HR=0.172; 95% CI, 0.111-0.266).
  • Superior survival in patients receiving ibrutinib vs ofatumumab: HR=0.591; 95% CI, 0.378-0.926; P=.0208.
  • Percentage of ibrutinib patients with complete remission/complete remission with incomplete marrow recovery as best response increased over time from 1% at 6 months to 9% at 42 months.

Limitations

  • Relatively young median patient age of 67 years.

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