Open-label, phase 2 study of blinatumomab after frontline R-chemotherapy in adults with newly diagnosed, high-risk DLBCL.

Abstract

This open-label, multicenter, single-arm, phase 2 study assessed the safety and efficacy of blinatumomab consolidation therapy in adult patients with newly diagnosed, high-risk diffuse large B-cell lymphoma (DLBCL; International Prognostic Index 3-5 and/or double-/triple-hit or double MYC/BCL-2 expressors) who achieved complete response (CR), partial response (PR), or stable disease (SD) following run-in with 6 cycles of R-chemotherapy (NCT03023878). Of the 47 patients enrolled, 28 received blinatumomab. Five patients (17.9%) experienced grade 4 treatment-emergent adverse events of interest (neutropenia, n = 4; infection, n = 1). Two deaths reported at the end of the study were unrelated to treatment with blinatumomab (disease progression, n = 1; infection, n = 1). 3/4 patients with PR and 4/4 patients with SD after R-chemotherapy achieved CR following blinatumomab. Consolidation with blinatumomab in patients with newly diagnosed, high-risk DLBCL who did not progress under R-chemotherapy was better tolerated than in previous studies where blinatumomab was used for treatment of patients with lymphoma.

• Authors: Deborah A Katz, Joan D Morris, Michael P Chu, Kevin A David, Catherine Thieblemont, Nicholas J Morley, Sharif S Khan, Andreas Viardot, Alejandro Martín García-Sancho, Guillermo Rodríguez-García, Mariana Bastos-Oreiro, Seung Tae Lee, William Kormany, Yuqi Chen, Hansen L Wong, Abraham A Anderson, Yuliya Katlinskaya, Ariel A Avilion, Tian Dai, Eva González-Barca
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 63 Issue 9 Pg. 2063-2073 (Sep 2022) ISSN: 1029-2403 [Electronic] United States
• PMID: 35503708 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bispecific
• Proto-Oncogene Proteins c-bcl-2
• blinatumomab

Topics

• Adult
• Antibodies, Bispecific (adverse effects)
• Humans
• Lymphoma, Large B-Cell, Diffuse (diagnosis, drug therapy)
• Proto-Oncogene Proteins c-bcl-2
• Remission Induction