Department of Hematology, Oncology and Pneumology, Comprehensive Cancer Center, University Medical School of the Johannes Gutenberg-University, Mainz, Germany.
Medizinische Klinik III, LMU Klinikum, Munich, Germany.
Leuk Lymphoma. 2024 Jan;65(1):14-25. doi: 10.1080/10428194.2023.2268228. Epub 2024 Jan 10.
The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure. Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons. Hazard ratios (95% confidence intervals) were 0.38 (0.23, 0.61) for IPW, 0.45 (0.28, 0.74) for RA, and 0.37 (0.23, 0.59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure.
学者-2 回顾性研究强调了复发/难治性 (R/R) 套细胞淋巴瘤 (MCL) 患者在接受共价布鲁顿酪氨酸激酶抑制剂 (BTKi) 治疗失败后，标准治疗 (SOC) 方案的总体生存 (OS) 较差。在 ZUMA-2 单臂试验中，brexucabtagene autoleucel (brexu-cel; 自体抗 CD19 CAR T 细胞疗法) 显示出 R/R MCL 患者在先前有 BTKi 暴露的情况下具有高比例的持久缓解率。在这里，我们使用三种不同的方法比较了 ZUMA-2 和 SCHOLAR-2 中的 OS，这些方法调整了人群之间预后因素的不平衡：逆概率加权 (IPW)、回归调整 (RA) 和双重稳健 (DR)。与 SOC 相比，brexu-cel 在所有未调整和调整后的比较中均与改善的 OS 相关。未经调整的风险比 (95%置信区间) 为 0.38 (0.23, 0.61)，RA 为 0.45 (0.28, 0.74)，DR 为 0.37 (0.23, 0.59)。这些结果表明，在接受 BTKi 治疗后，与 SOC 相比，brexu-cel 在 R/R MCL 患者中具有显著的生存获益。
