雅可派唑布替基炭酸鹽（axi-cel）在高风险复发/难治性大B细胞淋巴瘤（LBCL）患者中作为二线治疗显示出优于常规护理的疗效，这些患者被认为适合自体干细胞移植（ASCT）；然而，在临床实践中，约有一半的R/R LBCL患者被认为不适合ASCT。Alycante是一项开放标签的2期研究，评估了62名被认为不适合ASCT的R/R LBCL患者作为二线治疗接受axi-cel。主要终点是在axi-cel输注后3个月内调查员评估的完全代谢恢复。主要的次要终点包括无进展生存期、总生存期和安全性。该研究在3个月时达到了主要终点，完全代谢恢复率为71.0%（95%置信区间为58.1-81.8%）。在中位随访时间为12.0个月（范围为2.1-17.9）的情况下，中位无进展生存期为11.8个月（95%置信区间为8.4-未达到），总生存期尚未达到。没有发现意外毒性。8.1%的患者出现了3-4级细胞因子释放综合征，14.5%的患者出现了神经系统事件。这些结果支持axi-cel作为不适合ASCT的R/R LBCL患者的二线治疗。 ClinicalTrials.gov识别号为NCT04531046 。© 2023. 作者。

Axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy compared to standard of care as second-line therapy in patients with high-risk relapsed/refractory (R/R) large B cell lymphoma (LBCL) considered eligible for autologous stem cell transplantation (ASCT); however, in clinical practice, roughly half of patients with R/R LBCL are deemed unsuitable candidates for ASCT. The efficacy of axi-cel remains to be ascertained in transplant-ineligible patients. ALYCANTE, an open-label, phase 2 study, evaluated axi-cel as a second-line therapy in 62 patients with R/R LBCL who were considered ineligible for ASCT. The primary end point was investigator-assessed complete metabolic response at 3 months from the axi-cel infusion. Key secondary end points included progression-free survival, overall survival and safety. The study met its primary end point with a complete metabolic response of 71.0% (95% confidence interval, 58.1-81.8%) at 3 months. With a median follow-up of 12.0 months (range, 2.1-17.9), median progression-free survival was 11.8 months (95% confidence interval, 8.4-not reached) and overall survival was not reached. There was no unexpected toxicity. Grade 3-4 cytokine release syndrome and neurologic events occurred in 8.1% and 14.5% of patients, respectively. These results support axi-cel as second-line therapy in patients with R/R LBCL ineligible for ASCT. ClinicalTrials.gov Identifier: NCT04531046 .© 2023. The Author(s).