TCT 2019—Less treatment failure for chronic GVHD with ixazomib


  • Tara Haelle
  • Univadis
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Takeaway

  • Ixazomib reduced 6-month historical treatment failure rate for chronic graft vs host disease (cGVHD).

Why this matters

  • Patients with advanced cGVHD have limited treatment options for improved outcomes. 

Study design

  • Phase 2, single-arm trial at 6 institutions involving 50 adults with cGVHD.
    • 16% moderate, 84% severe cGVHD.
    • 80% classic, 20% overlap cGVHD.
    • 52% had ≥4 affected organs.
    • 78% had ≥3 previous lines of systemic therapy.
  • All had failure of ≥1 previous line of systemic immune suppressive (IS) therapy. 
  • Patients received 4 mg oral ixazomib on days 1, 8, and 15 of 28-day cycles for 6 cycles (or more for responders).

Key results

  • 26 patients completed 6 months of planned therapy with dose reductions primarily due to thrombocytopenia, fatigue, diarrhea, and infection; all continued some IS at 12 months.
  • 6-month treatment failure rate (death, relapse, or additional IS therapy) was 28% vs historical 44% (P=.01).
  • Overall response rate was 34% at 6 months.
  • 6- and 12-month survival was 92% and 90%, respectively. 
  • 38% experienced severe adverse events, with 2 of 5 deaths potentially treatment-related.

Highlights from TCT Meetings 2019