- Ibrutinib+rituximab extends PFS and OS relative to the current standard of care in patients aged ≤70 years with previously untreated CLL.
Why this matters
- Study establishes ibrutinib+rituximab as superior to the standard fludarabine+cyclophosphamide+rituximab (FCR).
- Phase 3 E1912 study of 529 treatment-naive patients aged 28-70 (median, 58) years with CLL randomly assigned 2:1 to ibrutinib+rituximab or FCR.
- Median follow-up, 33.4 months.
- Funding: National Cancer Institute; Pharmacyclics LLC
- Ibrutinib+rituximab extended PFS vs FCR (HR, 0.352; P<.00001>
- Ibrutinib+rituximab extended PFS vs FCR (HR, 0.168; P<.0003>
- Ibrutinib+rituximab benefit was independent of age, sex, performance status, disease stage, or the presence/absence of del11q23.
- Ibrutinib+rituximab was superior to FCR for PFS in patients with unmutated IGHV (HR, 0.262; P<.0001 but not mutated ighv p=".07).</li">
- Rates of any grade ≥3 adverse events were lower with ibrutinib+rituximab vs FCR (58.5% vs 72.1%; P=.0004).
- Specifically, rates of grade 3-4 neutropenia, anemia, thrombocytopenia, and any infection were lower with ibrutinib+rituximab vs FCR (all P<.001>
- Patients with deletion 17p excluded.
- Further monitoring needed to determine durability of responses.