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 ( identifiers: #NCT02348216 and #NCT03391466, respectively) are registered on .

中文翻译：

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使用 axicabtagene ciloleucel 治疗大 B 细胞淋巴瘤的跨种族和民族的真实世界和临床试验结果


Axicabtagene ciloleucel (axi-cel) 是一种自体抗 CD19 嵌合抗原受体 (CAR) T 细胞疗法，被批准用于治疗复发/难治性 (R/R) 大 B 细胞淋巴瘤 (LBCL)。尽管有大量数据支持其使用，但按种族和族裔群体分层的结果有限。在这里，我们报告了现实世界和临床试验环境中按种族和民族划分的 R/R LBCL 患者使用 axi-cel 的临床结果。在现实世界中，国际血液和骨髓移植研究中心数据库确定了 2017 年至 2020 年期间接受 axi-cel 的 1290 名患者； ZUMA-1 和 ZUMA-7 试验分别纳入了 106 名和 169 名患者。不同种族/民族的总体生存率是一致的。然而，与非西班牙裔 (NH) 白人患者相比，非西班牙裔 (NH) 黑人患者的总体缓解率 (OR, 0.37; 95% CI, 0.22-0.63) 和完全缓解率 (OR, 0.57; 95% CI, 0.33-0.97) 较低。与 NH 白人（HR，1.41；95% CI，1.04-1.90）和 NH 亚洲患者（HR，1.67；95% CI，1.08-2.59）相比，NH 黑人患者的无进展生存期也较短。 NH 亚洲患者的反应持续时间比 NH 白人患者（HR，0.56；95% CI，0.33-0.94）和西班牙裔患者（HR，0.54；95% CI，0.30-0.97）更长。细胞因子释放综合征不存在种族/民族差异；然而，NH White 患者中任何级别的免疫效应细胞相关神经毒性综合征的发生率高于其他患者。这些结果为使用 CAR T 细胞疗法治疗不同种族和民族的 R/R LBCL 患者提供了重要背景。 ZUMA-1 和 ZUMA-7（标识符：分别为 #NCT02348216 和 #NCT03391466）已在 上注册。