- 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.
- 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.
- 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.
- Relatively young median patient age of 67 years.