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