Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia
The primary end point was progression‑free survival, as assessed by an independent review committee.
In a randomized phase 3 trial involving 150 symptomatic patients with Waldenström’s macroglobulinemia, adding ibrutinib to rituximab significantly improved progression‑free survival (82% at 30 months versus 28% with placebo‑rituximab), independent of MYD88 or CXCR4 genotype. The combination also yielded higher overall response (72% vs. 32%) and greater sustained hemoglobin improvement (73% vs. 41%) compared with placebo‑rituximab. Adverse events such as atrial fibrillation (12% vs. 1%) and hypertension (13% vs. 4%) were more frequent with ibrutinib, while infusion reactions and IgM flare were more common with placebo. The trial was funded by Pharmacyclics and Janssen Research and Development.
These findings demonstrate that ibrutinib plus rituximab provides durable disease control in Waldenström’s macroglobulinemia, an area where therapeutic options are limited, and inform clinical practice regarding benefit‑risk balance.
Bizonyítékszint: Állatkísérletes. Állatmodellben vizsgálták.
Kapcsolódó jelek
- Waldenström Macroglobulinemia Clinical Trials
- European Consortium for Waldenström's Macroglobulinemia
- Waldenström Macroglobulinemia - A State-of-the-Art Review: Part 2- Focus on Therapy
- The therapeutic perspective of relapsed/refractory Waldenström Macroglobulinemia: what comes next?
- Waldenstrom's Macroglobulinemia Clinical Trials and Research | Dana‑Farber Cancer Institute