Phase 2 Study of Daratumumab in Relapsed/Refractory Mantle-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

Clinical Lymphoma, Myeloma & Leukemia
Gilles SallesMichael Wang

Abstract

Daratumumab is a CD38 monoclonal antibody approved for treating relapsed/refractory and newly diagnosed multiple myeloma. Preclinical daratumumab studies demonstrated cytotoxic activity and reduced tumor growth in B-cell non-Hodgkin lymphoma (NHL) subtypes, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle-cell lymphoma (MCL). This was a phase 2, open-label, multicenter, 2-stage trial. Patients with relapsed/refractory DLBCL, FL, or MCL with ≥ 50% CD38 expression were eligible for stage 1. Daratumumab (16 mg/kg; 28-day cycles) was administered intravenously weekly for 2 cycles, every 2 weeks for 4 cycles, and every 4 weeks thereafter. Overall response rate was the primary end point. Pharmacokinetic and safety were also evaluated. Stage 2 was planned to further assess daratumumab in larger populations of NHL subtypes if futility criteria were not met. The study was registered with ClinicalTrials.gov (NCT02413489). The trial screened 138 patients resulting in accrual of 15 patients with DLBCL, 16 with FL, and 5 with MCL. Median CD38 expression across treated patients was 70%. Overall response rate was 6.7%, 12.5%, and not evaluable in DLBCL, FL, and MCL cohorts, respectively. The most common gr...Continue Reading

Citations

Feb 13, 2019·Journal of the National Cancer Institute·Bradley D Hunter, Caron A Jacobson
Oct 18, 2019·Expert Review of Hematology·Lori A LeslieAndre H Goy
Nov 30, 2019·Cells·Thomas G MartinKenneth C Anderson
Mar 21, 2020·Current Treatment Options in Oncology·Theodora Anagnostou, Stephen M Ansell
Mar 29, 2019·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Christina L Zuch de ZafraOlivier Nolan-Stevaux
Aug 30, 2020·Journal of Controlled Release : Official Journal of the Controlled Release Society·Ondřej LidickýTomáš Etrych
Jun 4, 2021·Journal of Blood Medicine·Marilyn T NedumcherilLjiljana V Vasovic
Sep 4, 2021·Acta Oncologica·Trine Engelbrecht HybelMaja Ludvigsen

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