Study
| Phase 3, multicenter, open-label trial [FLAIR ISRCTN01844152] |
| Previously untreated chronic lymphocytic leukemia (CLL) patients |
| Ibrutinib-venetoclax vs. Ibrutinib alone vs. Fludarabine-cyclophosphamide-rituximab (FCR) |
Efficacy
| Undetectable MRD in bone marrow within 2 yrs: 66.2% vs 0% vs 48.3% |
| 5-yr PFS: 93.9% vs 79.0% vs 58.1% |
| 5-yr OS: 95.9% vs 90.5% vs 86.5% |
| HR for death: 0.41 [0.20-0.83] vs 0.26 [0.13-0.50] |
Safety
| Grade >=3 AE: Neutropenia (27.2% vs 6.5% vs 47.3%) |
| Serious AEs: Infections (61 vs 66 vs 45) |
| Treatment discontinuations: 22.6% vs 37.7% vs 25.9% |
N Engl J Med. Published online on June 15, 2025
http://doi.org/10.1056/NEJMoa2504341
Reviewed by Elvin Chalabiyev, MD on Sep 3, 2025
