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Combination Targeted Therapy in Relapsed Diffuse Large B-Cell Lymphoma.

Christopher Melani1, Rahul Lakhotia1, Stefania Pittaluga1

  • 1From the Lymphoid Malignancies Branch (C. Melani, R.L., J.D.P., D.W.H., J.S., J.M., Y.Y., W.X., A.P., C. Morrison, A.T., A.M.J., M.R., L.M.S., W.H.W.), the Clinical Pharmacology Program (C.J.P., O.A., W.D.F.), the Molecular Imaging Branch (E.M., L.L., E.B.), and the Biostatistics and Data Management Section (S.M.S.), Center for Cancer Research, the Laboratory of Pathology, Clinical Center (S.P., T.D.-H., S.D.P., E.S.J.), and the Biometric Research Program, Division of Cancer Treatment and Diagnosis (G.W.), National Cancer Institute, the Division of Pre-Clinical Innovation Chemistry Technologies, National Center for Advancing Translational Sciences (C.J.T., M.C., F.A.T.), and the Clinical Center Pharmacy Department (C.L.), National Institutes of Health, Bethesda, and Greenebaum Comprehensive Cancer Center, University of Maryland Medical Center, Baltimore (S.T.L.) - all in Maryland; the Division of Hematology and Oncology, University of Virginia, Charlottesville (C.A.P.); Mario Lemieux Center for Blood Cancers, University of Pittsburgh School of Medicine, Pittsburgh (R.J.F.); and Adaptive Biotechnologies, Seattle (A.J., H.S.).

The New England Journal of Medicine
|June 20, 2024
PubMed
Summary
This summary is machine-generated.

The ViPOR regimen showed durable remissions in specific diffuse large B-cell lymphoma (DLBCL) subtypes. This combination therapy, including venetoclax, demonstrated manageable adverse events in relapsed or refractory DLBCL patients.

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Area of Science:

  • Oncology
  • Hematology
  • Clinical Pharmacology

Background:

  • Targeting oncogenic mutations in diffuse large B-cell lymphoma (DLBCL) has led to pathway-specific drugs.
  • The potential for curative treatment by targeting multiple survival pathways in DLBCL remains unknown.

Purpose of the Study:

  • To evaluate the safety and efficacy of a novel combination regimen, ViPOR, in patients with relapsed or refractory DLBCL.
  • To determine the recommended phase 2 dose of venetoclax within the ViPOR regimen.

Main Methods:

  • A single-center, phase 1b-2 study of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR) was conducted.
  • Phase 1b determined the recommended dose of venetoclax (800 mg), with phase 2 evaluating efficacy in DLBCL patients.
  • ViPOR was administered every 21 days for six cycles.

Main Results:

  • A dose-limiting toxicity of grade 3 intracranial hemorrhage established the phase 2 dose of venetoclax.
  • Among 48 evaluable DLBCL patients, objective response was 54% and complete response was 38%.
  • Complete responses were observed in non-GCB DLBCL and high-grade B-cell lymphoma with specific gene rearrangements; 2-year progression-free survival was 34% and overall survival was 36%.

Conclusions:

  • The ViPOR regimen achieved durable remissions in patients with specific molecular DLBCL subtypes.
  • Adverse events associated with ViPOR were primarily reversible.
  • The study was funded by the National Cancer Institute and others (ClinicalTrials.gov NCT03223610).