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

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

doi:10.1038/s41375-025-02532-7

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

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

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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. (Figure presented.)

Original language	English
Pages (from-to)	1058–1068
Number of pages	11
Journal	Leukemia
Volume	39
Issue number	5
Early online date	19 Mar 2025
DOIs	https://doi.org/10.1038/s41375-025-02532-7
Publication status	Published - 2025

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Shah, B. D., Cassaday, R. D., Park, J. H., Houot, R., Logan, A. C., Boissel, N., Leguay, T., Bishop, M. R., Topp, M. S., O'Dwyer, K. M., Tzachanis, D., Arellano, M. L., Lin, Y., Baer, M. R., Schiller, G. J., Subklewe, M., Abedi, M., Minnema, M. C., Wierda, W. G., ... Oluwole, O. O. (2025). Three-year analysis of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3. Leukemia, 39(5), 1058–1068 . https://doi.org/10.1038/s41375-025-02532-7

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

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. (Figure presented.)",

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

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025.",

year = "2025",

doi = "10.1038/s41375-025-02532-7",

language = "English",

volume = "39",

pages = "1058–1068 ",

journal = "Leukemia",

issn = "0887-6924",

publisher = "Springer Nature",

number = "5",

}

Shah, BD, Cassaday, RD, Park, JH, Houot, R, Logan, AC, Boissel, N, Leguay, T, Bishop, MR, Topp, MS, O'Dwyer, KM, Tzachanis, D, Arellano, ML, Lin, Y, Baer, MR, Schiller, GJ, Subklewe, M, Abedi, M, Minnema, MC, Wierda, WG, DeAngelo, DJ, Stiff, P, Jeyakumar, D, Mao, D, Adhikary, S, Zhou, L, Hadjivassileva, T, Damico Khalid, R, Ghobadi, A & Oluwole, OO 2025, 'Three-year analysis of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3', Leukemia, vol. 39, no. 5, pp. 1058–1068 . https://doi.org/10.1038/s41375-025-02532-7

TY - JOUR

T1 - Three-year analysis of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3

AU - Shah, Bijal D

AU - Cassaday, Ryan D

AU - Park, Jae H

AU - Houot, Roch

AU - Logan, Aaron C

AU - Boissel, Nicolas

AU - Leguay, Thibaut

AU - Bishop, Michael R

AU - Topp, Max S

AU - O'Dwyer, Kristen M

AU - Tzachanis, Dimitrios

AU - Arellano, Martha L

AU - Lin, Yi

AU - Baer, Maria R

AU - Schiller, Gary J

AU - Subklewe, Marion

AU - Abedi, Mehrdad

AU - Minnema, Monique C

AU - Wierda, William G

AU - DeAngelo, Daniel J

AU - Stiff, Patrick

AU - Jeyakumar, Deepa

AU - Mao, Daqin

AU - Adhikary, Sabina

AU - Zhou, Lang

AU - Hadjivassileva, Tsveta

AU - Damico Khalid, Rita

AU - Ghobadi, Armin

AU - Oluwole, Olalekan O

PY - 2025

Y1 - 2025

N2 - 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. (Figure presented.)

AB - 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. (Figure presented.)

UR - http://www.scopus.com/inward/record.url?scp=105000542487&partnerID=8YFLogxK

U2 - 10.1038/s41375-025-02532-7

DO - 10.1038/s41375-025-02532-7

M3 - Article

C2 - 40108332

SN - 0887-6924

VL - 39

SP - 1058

EP - 1068

JO - Leukemia

JF - Leukemia

IS - 5

ER -

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

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