European Hematology Association: Multicenter Open-label Phase 2 Study of ibrutinib in Chronic Graft Versus Host Disease (cGVHD) After Failure of Corticosteroids

MADRID, June 24, 2017 /PRNewswire/ --

Ibrutinib: A promising new treatment for chronic graft versus host disease. 

Chronic graft versus host disease (cGVHD) is a serious and life-threatening complication observed in most patients undergoing allogeneic stem cell transplantations. Both B and T cells are known to be involved in the pathophysiology of cGVHD. Ibrutinib, a Bruton's tyrosine kinase inhibitor, is known to inhibit B cells; recent studies have shown that ibrutinib also inhibits specific subsets of T cells by blocking interleukin-2-inducible T-cell kinase. In mouse models, ibrutinib delayed the progression and reduced the severity of cGVHD. This multicenter, open-label trial was conducted to evaluate the safety and efficacy of ibrutinib in 42 patients with active cGVHD whose disease had failed between 1 and 3 prior treatments; patients were given daily ibrutinib (420 mg) until cGVHD progression or dose limiting toxicity. At a median follow-up of 13.9 months, the AE profile shows largely low-grade events consistent with those reported for B cell malignancies treated with ibrutinib and those observed in cGVHD patients on corticosteroids. Serious AEs occurred in 22 patients (52%).  The overall cGVHD response rate was 67% with 71% of responders showing a sustained response for ≥ 20 weeks. Patients showed similar rates of response in all organ domains, and most patients with multi-organ disease responded in multiple organs. Corticosteroid doses were also reduced in most responders, and 5 responders discontinued corticosteroids completely. The clinical benefit make ibrutinib a promising treatment option for patients with cGVHD whose disease failed to respond to frontline therapy.

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Presenter:Dr Iskra Pusic

Affiliation: Washington University School of Medicine, St. Louis, MO, USA

Topic: IBRUTINIB FOR CHRONIC GRAFT-VERSUS-HOST DISEASE AFTER FAILURE OF FRONTLINE CORTICOSTEROIDS: RESULTS OF A MULTICENTER OPEN-LABEL PHASE 2 STUDY

Abstract S441 will be presented by Iskra Pusic on Saturday, June 24, 16:00 - 17:15 in Room N103.

About the EHA Annual Congress
Hematology is a specialty that covers everything to do with blood: its origin in the bone marrow, diseases of blood and their treatments. The latest data on research and developments will be presented. The topics range from stem cell physiology and development, to leukemia, lymphoma, myeloma - diagnosis and treatment; red blood cells -, white blood cells- and platelet disorders; thrombosis and bleeding disorders.