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The safety and efficacy of Ibrutinib in patients with CLL/SLL were demonstrated in one uncontrolled trial and five randomized, controlled trials.
The ORR was 58.3% (95% CI: 43.2%, 72.4%), all partial responses. None of the patients achieved a complete response. The DOR ranged from 5.6 to 24.2+ months. The median DOR was not reached.
The RESONATE study, a randomized, multicenter, open-label, phase 3 study of Ibrutinib versus ofatumumab (NCT01578707), was conducted in patients with previously treated CLL or SLL.
With an overall follow-up of 63 months, the median investigator-assessed PFS per IWCLL criteria was 44.1 months [95% CI (38.5, 56.9)] in the Ibrutinib arm and 8.1 months [95% CI (7.8, 8.3)] in the ofatumumab arm. Overall response rate as assessed by investigators was 87.2% in the Ibrutinib arm versus 22.4% in the ofatumumab arm.
from FDA，2024.05
