Odronextamab monotherapy in R/R DLBCL after progression with CAR T-cell therapy: primary analysis of the ELM-1 study

Patients with relapsed/refractory diffuse large B-cell lymphoma progressing after chimeric antigen receptor T-cell (CAR-T) therapy have dismal outcomes. The prespecified post-CAR-T expansion cohort of the ELM-1 study investigated the efficacy and safety of odronextamab, a CD20×CD3 bispecific antibody, in patients with disease progression after CAR-Ts. Sixty patients received IV odronextamab weekly for 4 cycles followed by maintenance until progression. The primary end point was objective response rate (ORR) by independent central review. The median number of prior lines of therapy was 3 (range, 2-9), 71.7% were refractory to CAR-Ts, and 48.3% relapsed within 90 days of CAR-T therapy. After a median follow-up of 16.2 months, ORR and complete response (CR) rate were 48.3% and 31.7%, respectively. Responses were similar across prior CAR-T products and time to relapse on CAR-T therapy. Median duration of response was 14.8 months and median duration of CR was not reached. Median progression-free survival and overall survival were 4.8 and 10.2 months, respectively. The most common treatment-emergent adverse event was cytokine release syndrome (48.3%; no grade ≥3 events). No cases of immune effector cell-associated neurotoxicity syndrome were reported. Grade ≥3 infections occurred in 12 patients (20.0%), 2 of which were COVID-19. Odronextamab monotherapy demonstrated encouraging efficacy and generally manageable safety, supporting its potential as an off-the-shelf option for patients after CAR-T therapy. This trial was registered at www.clinicaltrials.gov as #NCT02290951.

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Publication Details

Journal
Blood
Published
2024-12-30
DOI
https://doi.org/10.1182/blood.2024027044
Citations
21
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
5.93

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article

Odronextamab monotherapy in R/R DLBCL after progression with CAR T-cell therapy: primary analysis of the ELM-1 study

Jurriaan Brouwer‐Visser, Dina M. Flink, Susan O’Brien, Jon Arnason et al.
21 citations
Blood
CAR-T cell therapy research
5.93
article

Odronextamab monotherapy in R/R DLBCL after progression with CAR T-cell therapy: primary analysis of the ELM-1 study

Jurriaan Brouwer‐Visser, Dina M. Flink, Susan O’Brien, Jon Arnason, Srikanth Ambati, John Nathan Allan, Jeffrey A. Barnes, Hesham Mohamed, Matthew J. Matasar, Stephen M. Ansell, Uri Abadi, Neta Goldschmidt, Jean‐Marie Michot, Jennifer Leigh Crombie, Max S. Topp, Min Zhu, Yuan Cheng, I. Avivi, Aafia Chaudhry
article en
21 citations

Abstract

Patients with relapsed/refractory diffuse large B-cell lymphoma progressing after chimeric antigen receptor T-cell (CAR-T) therapy have dismal outcomes. The prespecified post-CAR-T expansion cohort of the ELM-1 study investigated the efficacy and safety of odronextamab, a CD20×CD3 bispecific antibody, in patients with disease progression after CAR-Ts. Sixty patients received IV odronextamab weekly for 4 cycles followed by maintenance until progression. The primary end point was objective response rate (ORR) by independent central review. The median number of prior lines of therapy was 3 (range, 2-9), 71.7% were refractory to CAR-Ts, and 48.3% relapsed within 90 days of CAR-T therapy. After a median follow-up of 16.2 months, ORR and complete response (CR) rate were 48.3% and 31.7%, respectively. Responses were similar across prior CAR-T products and time to relapse on CAR-T therapy. Median duration of response was 14.8 months and median duration of CR was not reached. Median progression-free survival and overall survival were 4.8 and 10.2 months, respectively. The most common treatment-emergent adverse event was cytokine release syndrome (48.3%; no grade ≥3 events). No cases of immune effector cell-associated neurotoxicity syndrome were reported. Grade ≥3 infections occurred in 12 patients (20.0%), 2 of which were COVID-19. Odronextamab monotherapy demonstrated encouraging efficacy and generally manageable safety, supporting its potential as an off-the-shelf option for patients after CAR-T therapy. This trial was registered at www.clinicaltrials.gov as #NCT02290951.

BloodVol. 145(14)
Rutgers, The State University of New Jersey (US), Beth Israel Deaconess Medical Center (US), Mayo Clinic (US), NewYork–Presbyterian Hospital (US), Harvard University (US), Tel Aviv University (IL), Regeneron (United States) (US), Hebrew University of Jerusalem (IL), University of California, Irvine (US), Cornell University (US), Université Paris-Saclay (FR), Hadassah Medical Center (IL), New York Hospital Queens (US), Meir Medical Center (IL), Institut Gustave Roussy (FR), Rebecca Sieff Hospital (IL), WinnMed (US), Massachusetts General Hospital (US), Presbyterian Hospital (US), University of California, Irvine Medical Center (US), Center for Neuro-Oncology (US), Dana-Farber Cancer Institute (US), Universitätsklinikum Würzburg (DE), Center for Cancer Research (US), Weill Cornell Medicine (US), Rutgers Cancer Institute (US)
Regeneron Pharmaceuticals
Good health and well-being
Openalex Percentile: Top 3%
CAR-T cell therapy research
5.93
DOIOpen Access PDFOpenAlex
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