Ibrutinib (I) plus bendamustine and rituximab (BR) in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): a 2-year follow-up of the HELIOS study.

7525Background: The phase 3 HELIOS study evaluated I + BR vs placebo (P) + BR in patients (pts) with previously treated CLL/SLL. At first analysis (median follow-up: 17.0 months) progression-free survival (PFS) was significantly improved for I + BR vs P + BR (HR [95% CI]: 0.203 [0.15-0.28], pu003c 0.0001). Prior studies have shown deepening responses with continued ibrutinib treatment; long-term follow-up assessing durability and depth of response is important. Methods: 578 pts received BR (≤ 6 cycles) and were randomized 1:1 to I (420 mg daily) or P (N = 289/arm). Pts with del17p (≥ 20% of cells) were excluded. Primary end point was PFS. Key secondary end points: overall survival (OS), overall response rate (ORR), and rate of minimum residual disease negative (MRD -ve) response. Results: Median follow up is 25.4 months. I + BR continues to show improvement in PFS vs P + BR (investigator [INV]-assessed median: not reached [NR] vs 14.2 months; HR [95% CI]: 0.199 [0.15, 0.26], p u003c 0.0001; 2-yr rate: 74.8% vs 20...