Three-year analysis of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3 Journal Article
| Authors: | 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.; DeAngelo, D. J.; Stiff, P.; Jeyakumar, D.; Mao, D.; Adhikary, S.; Zhou, L.; Hadjivassileva, T.; Damico Khalid, R.; Ghobadi, A.; Oluwole, O. O. |
| Article 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.) © The Author(s) 2025. |
| Keywords: | adolescent; adult; aged; middle aged; survival rate; young adult; major clinical study; overall survival; fludarabine; mortality; chemotherapy; cytarabine; follow up; follow-up studies; neoplasm recurrence, local; thrombocytopenia; incidence; relapse; cyclophosphamide; dexamethasone; vincristine; antineoplastic activity; drug resistance; pathology; drug resistance, neoplasm; pneumonia; hypoxia; cause of death; hypotension; immunology; bone marrow biopsy; minimal residual disease; tumor recurrence; graft versus host reaction; long term care; remission; remission induction; sepsis; allogeneic hematopoietic stem cell transplantation; immunosuppressive treatment; immunoglobulin deficiency; neurologic disease; brain hemorrhage; therapy; adoptive immunotherapy; immunotherapy, adoptive; cd19 antigen; antigens, cd19; multiple organ failure; recurrence free survival; cardiopulmonary arrest; pharmacokinetic parameters; phase 2 clinical trial (topic); leukapheresis; phase 1 clinical trial (topic); inotuzumab ozogamicin; viremia; respiratory distress; acute respiratory distress syndrome; cytokine release syndrome; procedures; blinatumomab; very elderly; conditioning chemotherapy; humans; prognosis; human; male; female; article; b cell acute lymphoblastic leukemia; hemorrhagic shock; ecog performance status; precursor b-cell lymphoblastic leukemia-lymphoma; brexucabtagene autoleucel |
| Journal Title: | Leukemia |
| Volume: | 39 |
| Issue: | 5 |
| ISSN: | 0887-6924 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2025-05-01 |
| Start Page: | 1058 |
| End Page: | 1068 |
| Language: | English |
| DOI: | 10.1038/s41375-025-02532-7 |
| PUBMED: | 40108332 |
| PROVIDER: | scopus |
| PMCID: | PMC12055586 |
| DOI/URL: | |
| Notes: | Source: Scopus |
