Outcomes after brexucabtagene autoleucel administered as a standard therapy for adults with relapsed/refractory B-cell ALL Journal Article
| Authors: | Roloff, G. W.; Aldoss, I.; Kopmar, N. E.; Lin, C.; Dekker, S. E.; Gupta, V. K.; O’Connor, T. E.; Jeyakumar, N.; Muhsen, I. N.; Valtis, Y.; Ahmed, N.; Zhang, A.; Miller, K.; Dykes, K. C.; Ahmed, M.; Chen, E. C.; Mercadal, S.; Schwartz, M.; Tracy, S. I.; Dholaria, B.; Mukherjee, A.; Battiwalla, M.; Logan, A. C.; Ladha, A.; Guzowski, C.; Hoeg, R. T.; Hilal, T.; Moore, J.; Connor, M. P.; Hill, L. C.; Tsai, S. B.; Sasine, J. P.; Solh, M. M.; Kota, V. K.; Koura, D.; Veeraputhiran, M.; Leonard, J. T.; Frey, N. V.; Park, J. H.; Luskin, M. R.; Bachanova, V.; Galal, A.; Pullarkat, V.; Stock, W.; Cassaday, R. D.; Shah, B. D.; Faramand, R.; Muffly, L.; on behalf of the ROCCA Consortium |
| Article Title: | Outcomes after brexucabtagene autoleucel administered as a standard therapy for adults with relapsed/refractory B-cell ALL |
| Abstract: | PURPOSE On the basis of the results of the ZUMA-3 trial, brexucabtagene autoleucel (brexu-cel), a CD19-directed chimeric antigen receptor T-cell therapy, gained US Food and Drug Administration approval in October 2021 for adults with relapsed/refractory (R/R) B-cell ALL (B-ALL). We report outcomes of patients treated with brexu-cel as a standard therapy. METHODS We developed a collaboration across 31 US centers to study adults with B-ALL who received brexu-cel outside the context of a clinical trial. Data were collected retrospectively from October 2021 to October 2023. Toxicities were graded per American Society for Transplantation and Cellular Therapy guidelines for cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). RESULTS At the time of data lock, 204 patients had undergone apheresis and 189 were infused. Median follow-up time was 11.4 months. Forty-two percent of patients received brexu-cel in morphologic remission and would have been ineligible for participation in ZUMA-3. After brexu-cel, 151 achieved complete remission (CR), of which 79% were measurable residual disease (MRD) negative remissions. Median progression-free survival (PFS) was 9.5 months and median overall survival was not reached. Grade 3-4 CRS or ICANS occurred in 11% and 31%, respectively. In multivariable analysis, patients receiving consolidative hematopoietic cell transplantation (HCT; hazard ratio, 0.34 [95% CI, 0.14 to 0.85]) after brexu-cel had superior PFS compared with those who did not receive any consolidation or maintenance therapy. CONCLUSION Similar to ZUMA-3, high rates of MRD-negative CR were observed after brexu-cel treatment for R/R B-ALL. The use of HCT as consolidation after brexu-cel resulted in improved PFS. © 2024 by American Society of Clinical Oncology. |
| Keywords: | adolescent; adult; cancer chemotherapy; controlled study; treatment outcome; treatment response; aged; middle aged; retrospective studies; young adult; major clinical study; overall survival; fludarabine; clinical trial; mortality; neutropenia; united states; follow up; cancer immunotherapy; progression free survival; infection; cohort analysis; cyclophosphamide; steroid; hematopoietic stem cell transplantation; retrospective study; protein tyrosine kinase inhibitor; drug fatality; immunology; multicenter study; chimeric antigen receptor; drug therapy; leukemia relapse; mycosis; therapy; adoptive immunotherapy; immunotherapy, adoptive; cd19 antigen; antigens, cd19; biological product; biological products; cladribine; leukemia remission; adverse event; apheresis; inotuzumab ozogamicin; clinical outcome; refractory cancer; tocilizumab; blinatumomab; ponatinib; humans; human; male; female; article; b cell acute lymphoblastic leukemia; anakinra; receptors, chimeric antigen; precursor b-cell lymphoblastic leukemia-lymphoma; brexucabtagene autoleucel |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 43 |
| Issue: | 5 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2025-02-10 |
| Start Page: | 558 |
| End Page: | 566 |
| Language: | English |
| DOI: | 10.1200/jco.24.00321 |
| PUBMED: | 39418622 |
| PROVIDER: | scopus |
| PMCID: | PMC12070553 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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