Real-world and clinical trial outcomes in large B-cell lymphoma with axicabtagene ciloleucel across race and ethnicity Journal Article
| Authors: | Locke, F. L.; Siddiqi, T.; Jacobson, C. A.; Ghobadi, A.; Ahmed, S.; Miklos, D. B.; Perales, M. A.; Munoz, J.; Fingrut, W. B.; Pennisi, M.; Gauthier, J.; Shadman, M.; Gowda, L.; Mirza, A. S.; Abid, M. B.; Hong, S.; Majhail, N. S.; Kharfan-Dabaja, M. A.; Khurana, A.; Badar, T.; Lin, Y.; Bennani, N. N.; Herr, M. M.; Hu, Z. H.; Wang, H. L.; Baer, A.; Baro, E.; Miao, H.; Spooner, C.; Xu, H.; Pasquini, M. C. |
| Article Title: | Real-world and clinical trial outcomes in large B-cell lymphoma with axicabtagene ciloleucel across race and ethnicity |
| Abstract: | Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Despite extensive data supporting its use, outcomes stratified by race and ethnicity groups are limited. Here, we report clinical outcomes with axi-cel in patients with R/R LBCL by race and ethnicity in both real-world and clinical trial settings. In the real-world setting, 1290 patients who received axi-cel between 2017 and 2020 were identified from the Center for International Blood and Marrow Transplant Research database; 106 and 169 patients were included from the ZUMA-1 and ZUMA-7 trials, respectively. Overall survival was consistent across race/ethnicity groups. However, non-Hispanic (NH) Black patients had lower overall response rate (OR, 0.37; 95% CI, 0.22-0.63) and lower complete response rate (OR, 0.57; 95% CI, 0.33-0.97) than NH White patients. NH Black patients also had a shorter progression-free survival vs NH White (HR, 1.41; 95% CI, 1.04-1.90) and NH Asian patients (HR, 1.67; 95% CI, 1.08-2.59). NH Asian patients had a longer duration of response than NH White (HR, 0.56; 95% CI, 0.33-0.94) and Hispanic patients (HR, 0.54; 95% CI, 0.30-0.97). There was no difference in cytokine release syndrome by race/ethnicity; however, higher rates of any-grade immune effector cell–associated neurotoxicity syndrome were observed in NH White patients than in other patients. These results provide important context when treating patients with R/R LBCL with CAR T-cell therapy across different racial and ethnic groups. ZUMA-1 and ZUMA-7 (ClinicalTrials.gov identifiers: #NCT02348216 and #NCT03391466, respectively) are registered on ClinicalTrials.gov. © 2024 American Society of Hematology |
| Keywords: | adult; controlled study; treatment response; middle aged; major clinical study; overall survival; clinical trial; neutropenia; drug safety; chemotherapy; neurotoxicity; follow up; sensitivity analysis; progression free survival; lung disease; thrombocytopenia; prevalence; autologous stem cell transplantation; histology; comorbidity; cell therapy; corticosteroid; ethnic group; ethnicity; infusion; national health organization; caucasian; race; hispanic; clinical trial (topic); asian; leukapheresis; geographic distribution; clinical outcome; cytokine release syndrome; overall response rate; diffuse large b cell lymphoma; tocilizumab; Common Terminology Criteria for Adverse Events; human; male; female; article; ecog performance status; chimeric antigen receptor t-cell immunotherapy; axicabtagene ciloleucel |
| Journal Title: | Blood |
| Volume: | 143 |
| Issue: | 26 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2024-06-27 |
| Start Page: | 2722 |
| End Page: | 2734 |
| Language: | English |
| DOI: | 10.1182/blood.2023023447 |
| PUBMED: | 38635762 |
| PROVIDER: | scopus |
| PMCID: | PMC11251200 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work