- 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.
- 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.
- 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.
- Limited sample size for some disease characteristics.