Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Kite, A Gilead Company, Santa Monica, CA, USA.
Expert Rev Anticancer Ther. 2023 Feb;23(2):199-206. doi: 10.1080/14737140.2023.2171994. Epub 2023 Feb 10.
In the ZUMA-5 trial (Clinical trials identification: NCT03105336), axicabtagene ciloleucel (axi-cel; a chimeric antigen receptor T-cell therapy) demonstrated high rates of durable response in relapsed/refractory (r/r) follicular lymphoma (FL) patients and clear superiority relative to the SCHOLAR-5 external control cohort. We update this comparison using the ZUMA-5 24-month data.
The SCHOLAR-5 cohort is comprised of r/r FL patients who initiated ≥3 line of therapy after July 2014 and meeting ZUMA-5 eligibility criteria. Groups were balanced for patient characteristics through propensity scoring on prespecified prognostic factors using standardized mortality ratio (SMR) weighting. The overall response rate was compared using a weighted logistic regression. Time-to-event outcomes were evaluated using a Cox regression.
For SCHOLAR-5, the sum of weights for the 143 patients was 85 after SMR weighting, versus 86 patients in ZUMA-5. The median follow-up was 29.4 months and 25.4 months for ZUMA-5 and SCHOLAR-5, respectively. The hazard ratios for overall survival and progression-free survival were 0.52 (95% confidence interval (CI): 0.28-0.95) and 0.28 (95% CI: 0.17-0.45), favoring axi-cel.
This updated analysis, using a longer minimum follow-up than a previously published analysis, shows that the improved efficacy of axi-cel, relative to available therapies, in r/r FL is durable. .
在 ZUMA-5 试验（临床试验识别号：NCT03105336）中，axicabtagene ciloleucel（axi-cel；嵌合抗原受体 T 细胞疗法）在复发/难治性（r/r）滤泡淋巴瘤（FL）患者中显示出高比例的持久缓解率，并相对于 SCHOLAR-5 外部对照队列具有明显优势。我们使用 ZUMA-5 的 24 个月数据对此进行了更新。
SCHOLAR-5 队列由 r/r FL 患者组成，这些患者在 2014 年 7 月后接受了≥3 线治疗，并符合 ZUMA-5 的入选标准。通过基于预设预后因素的标准化死亡率（SMR）加权对患者特征进行倾向评分，使两组在患者特征上达到平衡。使用加权逻辑回归比较总体缓解率。使用 Cox 回归评估生存时间事件。
对于 SCHOLAR-5，143 名患者的权重总和在 SMR 加权后为 85，而 ZUMA-5 中有 86 名患者。中位随访时间分别为 ZUMA-5 和 SCHOLAR-5 的 29.4 个月和 25.4 个月。总生存和无进展生存的风险比分别为 0.52（95%置信区间（CI）：0.28-0.95）和 0.28（95% CI：0.17-0.45），有利于 axi-cel。
与之前发表的分析相比，此次使用更长的最小随访时间进行的更新分析表明，axi-cel 在 r/r FL 中的疗效优于现有疗法，且持久。
