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UNITY-NHL

Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma

Phase 2N = 208NCT02793583

Population
Relapsed or refractory marginal zone, follicular or small lymphocytic lymphoma unresponsive to prior treatments.
Design
Multicohort, open-label phase IIb study of umbralisib 800 mg orally once daily until progression, unacceptable toxicity or withdrawal in 208 patients with relapsed or refractory marginal zone, follicular or small lymphocytic lymphoma (at least 1 prior line for marginal zone; at least 2 for follicular and small lymphocytic) including at least one anti-CD20-based therapy. Primary endpoint: overall response rate.
Primary endpoint
ORR
Arms
  • Umbralisib (experimental, n = 208): Umbralisib 800 mg orally once daily
People
Fowler NH
Show the numbers
Results reported for UNITY-NHL
EndpointAnalysisUmbralisibControlEffect
ORRAll 208 patients (marginal zone, follicular and small lymphocytic lymphoma combined)primarymedian follow-up 27.7 monthsFowler 202147.1%—Median follow-up 27.7 months for efficacy. The abstract gives no follicular-lymphoma-specific response rate.
PFSFollicular lymphoma cohort (cohort size not given in the abstract)primaryFowler 2021median 10.6 months—Median duration of response in the follicular lymphoma cohort was 11.1 months. Secondary endpoint.
Results reported for UNITY-NHL
EndpointAnalysisUmbralisibControlEffect
ORRAll 208 patients (marginal zone, follicular and small lymphocytic lymphoma combined)primarymedian follow-up 27.7 monthsFowler 202147.1%—Median follow-up 27.7 months for efficacy. The abstract gives no follicular-lymphoma-specific response rate.
PFSFollicular lymphoma cohort (cohort size not given in the abstract)primaryFowler 2021median 10.6 months—Median duration of response in the follicular lymphoma cohort was 11.1 months. Secondary endpoint.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Umbralisib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsUmbralisib
0100.0%
763.3%
1342.7%
2027.0%
2717.1%
Primary publication: Fowler NH, Samaniego F, Jurczak W, Ghosh N, Derenzini E, Reeves JA, et al. Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2021;39(15):1609-1618. PubMedDOI

Appears in

Sources

  1. Fowler NH, Samaniego F, Jurczak W, Ghosh N, Derenzini E, Reeves JA, et al. Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2021;39(15):1609-1618.

    PubMedDOI