Ibrutinib-Rituximab Meets Primary Endpoint in Phase 3 Trial
In August 2018, the US Food and Drug Administration approved the combination of ibrutinib (Imbruvcia) and rituximab (Rituxan) as the first chemotherapy-free regimen for patients with Waldenström’s macroglobulinemia (or lymphoplasmacytic lymphoma) after positive results from a phase 3 trial. The study enrolled 150 symptomatic patients who were randomly assigned to rituximab with ibrutinib or with placebo. At a median of 30 months, the progression-free survival rate was 82% in the ibrutinib/rituximab arm versus 28% in the placebo arm (hazard ratio for progression or death, 0.20; P <.001). The ibrutinib/rituximab combination was also associated with a higher rate of major response than placebo/rituximab (72% vs 32%, respectively; P <.001) and a higher rate of sustained increases in hemoglobin level (73% vs 42%, respectively; P <.001).
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Dimopoulos MA, Tedeschi A, Trotman J, et al; iNNOVATE Study Group and the European Consortium for Waldenström’s Macroglobulinemia. Phase 3 trial of ibrutinib plus rituximab in Waldenström’s macroglobulinemia. N Engl J Med. 2018;378(25):2399-2410. doi: 10.1056/NEJMoa1802917.