Three-year analysis of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3

Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 CAR T-cell therapy approved in the US to treat adults aged ≥18 years (≥26 years in the EU) with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). Brexu-cel showed an overall complete remission (CR)/CR with incomplete hematologic recovery (CRi) rate of 73% (CR rate 60%) and median overall survival (OS) of 25.4 months in 78 patients with R/R B-ALL after 2 years in ZUMA-3. Here, we report updated outcomes after >3 years median follow-up. As of July 23, 2022, median follow-up in all patients (N = 78) was 41.6 months. Median OS (95% CI) was 25.6 months (1.2-47.0; N = 78) and was 38.9 months (25.4-not estimable) for responders (n = 58), with 9 patients in ongoing remission without subsequent therapies. Five deaths (none deemed brexu-cel-related) occurred since prior data cut. Benefits from brexu-cel were maintained regardless of age, prior therapies, and subsequent allogeneic stem cell transplantation (alloSCT). Subsequent alloSCT was not associated with survival benefit among responders versus responders without subsequent alloSCT. No secondary T-cell malignancies were reported in ZUMA-3 with long-term follow-up.

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Publication Details

Journal
Leukemia
Published
2025-03-19
DOI
https://doi.org/10.1038/s41375-025-02532-7
Citations
22
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
23.00

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article

Three-year analysis of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3

Marion Subklewe, Kristen Marie O’Dwyer, Patrick J. Stiff, Martha Arellano et al.
22 citations
Leukemia
CAR-T cell therapy research
23.00
article

Three-year analysis of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3

Marion Subklewe, Kristen Marie O’Dwyer, Patrick J. Stiff, Martha Arellano, Mehrdad Abedi, Tsveta Hadjivassileva, Bijal Shah, Deepa Jeyakumar, Lang Zhou, Roch Houot, Gary J. Schiller, Thibaut Leguay, Olalekan O. Oluwole, Daqin Mao, Monique C. Minnema, Maria R. Baer, Aaron C. Logan, Ryan D. Cassaday, Nicolas Boissel, Dimitrios Tzachanis, Daniel J. DeAngelo, Armin Ghobadi, William G. Wierda, Michael R. Bishop, Yi Lin, Max S. Topp, Jae H. Park, Sabina Adhikary, Rita Damico Khalid
article en
22 citations

Abstract

Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 CAR T-cell therapy approved in the US to treat adults aged ≥18 years (≥26 years in the EU) with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). Brexu-cel showed an overall complete remission (CR)/CR with incomplete hematologic recovery (CRi) rate of 73% (CR rate 60%) and median overall survival (OS) of 25.4 months in 78 patients with R/R B-ALL after 2 years in ZUMA-3. Here, we report updated outcomes after >3 years median follow-up. As of July 23, 2022, median follow-up in all patients (N = 78) was 41.6 months. Median OS (95% CI) was 25.6 months (1.2-47.0; N = 78) and was 38.9 months (25.4-not estimable) for responders (n = 58), with 9 patients in ongoing remission without subsequent therapies. Five deaths (none deemed brexu-cel-related) occurred since prior data cut. Benefits from brexu-cel were maintained regardless of age, prior therapies, and subsequent allogeneic stem cell transplantation (alloSCT). Subsequent alloSCT was not associated with survival benefit among responders versus responders without subsequent alloSCT. No secondary T-cell malignancies were reported in ZUMA-3 with long-term follow-up.

LeukemiaVol. 39(5)
University of Maryland, Baltimore (US), Memorial Sloan Kettering Cancer Center (US), The University of Texas MD Anderson Cancer Center (US), Emory University (US), Inserm (FR), University of California, Los Angeles (US), Loyola University Chicago (US), Vanderbilt University (US), University of Washington (US), Washington University in St. Louis (US), University of Rochester Medical Center (US), Centre Hospitalier Universitaire de Bordeaux (FR), University Medical Center Utrecht (NL), Moffitt Cancer Center (US), University of California San Diego (US), University of Chicago (US), Fred Hutch Cancer Center (US), University of California, Irvine Medical Center (US), University of California San Francisco Medical Center (US), Dana-Farber Cancer Institute (US), Hôpital Cardiologique du Haut-Lévêque (FR), Mayo Clinic in Arizona (US), Universitätsklinikum Würzburg (DE), Hôpital Saint-Louis (FR), Centre Hospitalier Universitaire de Rennes (FR), University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, UC Davis Comprehensive Cancer Center, Université de Rennes (FR), Ludwig-Maximilians-Universität München (DE), University of California, Davis (US)
Gilead Sciences
Good health and well-being
Openalex Percentile: Top 0%
CAR-T cell therapy research
23.00
DOIOpen Access PDFOpenAlex
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