AACR 2019—Umbralisib delivers 52% response rate in marginal zone lymphoma


  • Univadis
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Takeaway

  • Umbralisib is active and well-tolerated in patients with relapsed or refractory marginal zone lymphoma (R/R MZL).

Why this matters

  • Relapse in patients with rituximab-experienced MZL is common. Salvage therapies are not suitable for all.
  • Umbralisib is an oral, next-generation PI3K-δ inhibitor that inhibits casein kinase 1 (CK1)-ε and has demonstrated lower rates of immune-mediated toxicity.

Study design

  • Analysis of data from first 42 patients enrolled in the 69-patient phase 2b multicenter, open-label UNITY-NHL trial of umbralisib for R/R MZL (23 extranodal, 12 nodal, 7 splenic). 
  • All patients received ≥1 prior therapy including ≥1 CD20 mAb-containing regimen and at least 9 months of follow-up (median follow-up: 10.1 months).
  • Funding: TG Therapeutics.

Key results

  • 12-month PFS was 66% (median PFS not reached).
  • Objective response rate was 52% (57% for extranodal, 42% for nodal, and 43% for splenic).
    • 19% had complete response, 33% had partial response, 36% had stable disease, and 7% had disease progression.
  • Most common adverse events (AEs): diarrhea, nausea, fatigue, headache, cough, and decreased appetite.
  • Most common grade 3/4 events: diarrhea (10%), transaminitis (9%), and neutropenia (7%).
  • 19 patients had discontinued treatment as of cutoff date, primarily due to disease progression (10) and umbralisib-related AE (5).

Limitations

  • Small number of patients, short follow-up time.

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