![]() ![]() Ibrutinib is an oral, once-daily inhibitor of Bruton’s tyrosine kinase, an essential enzyme in the B cell receptor signaling pathway. These long-term data support improved survival outcomes and deepening responses with ibrutinib+BR compared with BR in relapsed CLL/SLL. Incidence of treatment-emergent adverse events (including grades 3–4) were generally consistent with the initial HELIOS report. Minimal residual disease (MRD)-negative response rates were 26.3% for ibrutinib+BR and 6.2% for placebo+BR ( P < 0.0001). Median overall survival was not reached in either arm HR (95% CI) for ibrutinib+BR versus placebo: 0.652 (0.454–0.935 P = 0.019). The results are consistent with the primary analysis findings (HR = 0.203, as assessed by independent review committee, with 17-month median follow-up). ![]() Investigator-assessed median progression-free survival (PFS) was not reached for ibrutinib+BR, versus 14.3 months for placebo+BR (hazard ratio, 0.206 P < 0.0001) 36-month PFS rates were 68.0% versus 13.9%, respectively. Overall, 578 patients were randomized 1:1 to either ibrutinib (420 mg daily) or placebo, in combination with 6 cycles of BR, followed by ibrutinib or placebo alone. We report follow-up results from the randomized, placebo-controlled, phase 3 HELIOS trial of ibrutinib+bendamustine and rituximab (BR) for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) without deletion 17p. ![]()
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