The Bruton’s Tyrosine Kinase (BTK) Inhibitor
O'Brien S, Furman R, Fowler N, et al.
Key Points:
Investigators intend to evaluate safety based on time on ibrutinib therapy (≤1 year & >1 year) in treatment naive (TN) and relapsed/refractory (RR) CLL/SLL patient populations
Median treatment duration of 21.5 months: 109/148 patients continued treatment with ibrutinib >1 year
Grade 3 or higher serious adverse event (SAE), including those determined to be related to study drug, declined over time
AEs leading to discontinuation: 12/148 patients within first year & 6/109 patients after first year of treatment
ORR: TN= 86.2%; RR= 88.3%
After median follow up of 27.2 months for responders with PR or better: median DOR not reached
76.1% of the responders alive without progression at 30 months.
Implications:
- Ibrutinib as single agent demonstrates long-term safety, tolerability, and durability of response in patients with TN and RR CLL/SLL.
View the original abstract on the ASH website.
