R/R CLL: ibrutinib maintains efficacy advantage at 6 years

  • Munir T & al.
  • Am J Hematol
  • 11 Sep 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In the final analysis of a phase 3 trial of ibrutinib vs ofatumumab in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), ibrutinib maintained its efficacy benefit even in patients with high-risk disease characteristics.

Why this matters

  • Data from the RESONATE study supported the full FDA approval of ibrutinib for CLL/SLL, including in patients with del(17p) disease.

Study design

  • 6-year follow-up of the RESONATE study of ibrutinib monotherapy (n=195) vs ofatumumab monotherapy (n=196) in patients with R/R CLL/SLL.
  • Funding: Pharmacyclics LLC; Janssen Pharmaceuticals.

Key results

  • 91% cumulative objective response rate (ORR) with ibrutinib.
  • Median investigator-assessed PFS, 44.1 (95% CI, 38.5-56.2) months with ibrutinib vs 8.1 (95% CI, 7.8-8.3) months with ofatumumab.
    • Significantly longer PFS with ibrutinib: HR, 0.148; 95% CI, 0.113-0.196; P<.0001.>
  • In patients with high-risk disease characteristics:
    • Median investigator-assessed PFS, 44.1 (95% CI, 38.5-56.9) months with ibrutinib vs 8.0 (95% CI, 6.4-8.2) months with ofatumumab.
  • 68% of patients in the ofatumumab group crossed over to ibrutinib:
    • Improved OS (censored at time of crossover) with ibrutinib vs ofatumumab: HR, 0.639; 95% CI, 0.418-0.975.
  • No new safety signals observed.

Limitations

  • Limited sample size for some disease characteristics.