CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Ciltacabtagene Autoleucel Versus Idecabtagene Vicleucel in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma with 2-4 Prior Lines of Therapy: Updated Matching-Adjusted Indirect Comparison.
Ciltacabtagene Autoleucel Versus Idecabtagene Vicleucel in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma with 2-4 Prior Lines of Therapy: Updated Matching-Adjusted Indirect Comparison.
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这项更新的 MAIC 具有更长的随访时间，显示在既往接受过 2-4 线治疗的三类暴露 RRMM 患者中，cilta-cel 在 PFS、OS 和缓解结局方面显著优于 ide-cel。OS 结果进一步证实了 cilta-cel 在该人群中的附加价值。
通过非锚定匹配调整间接比较（MAIC），使用CARTITUDE-4和CARTITUDE-1（cilta-cel）以及KarMMa-3（ide-cel）试验的数据，评估了ciltacabtagene autoleucel（cilta-cel）与idecabtagene vicleucel（ide-cel）在复发/难治性多发性骨髓瘤（RRMM）中的相对疗效。本次更新的MAIC纳入了更长的随访时间和总生存期（OS）。
采用非锚定MAIC方法，利用CARTITUDE-4（既往1-3线治疗，n = 208）和CARTITUDE-1（既往3-4线治疗，n = 37）的个体患者水平数据（IPD）进行分析。筛选符合KarMMa-3入组标准（既往2-4线治疗，三药暴露）的患者，并将结局与已发表的KarMMa-3汇总数据进行比较。对cilta-cel IPD进行加权，以在预先确定的关键预后因素上匹配KarMMa-3报告的基线特征。比较疗效评估指标包括PFS、OS、ORR、VGPR或更好缓解率以及CR或更好缓解率。
共纳入来自CARTITUDE-4和CARTITUDE-1的85例患者。经调整后，与ide-cel相比，cilta-cel组患者（有效样本量=39）的PFS风险降低58%[风险比（HR）0.42（95% CI 0.26-0.68）；p=0.0004]，OS风险降低42%[HR 0.58（0.34-0.99）；p=0.0452]。与ide-cel相比，cilta-cel组患者达到总体缓解的可能性显著更高[相对缓解比（RR）1.22（95% CI 1.08-1.38）；p=0.0126]，且缓解深度更深[≥ VGPR：RR 1.37（1.19-1.59）；p=0.0009；≥ CR：RR 1.80（1.49-2.18）；p < 0.0001]。
An unanchored MAIC was performed utilizing individual patient-level data (IPD) from CARTITUDE-4 [1-3 prior lines of therapy (LOT); n = 208] and CARTITUDE-1 (3-4 prior LOT; n = 37). Patients fulfilling KarMMa-3 inclusion criteria (2-4 prior LOT, triple-class exposed) were selected, and outcomes were compared against published aggregate KarMMa-3 data. Cilta-cel IPD were weighted to match reported baseline characteristics of KarMMa-3 on key prognostic factors identified a priori. Comparative efficacy was estimated for progression-free survival (PFS), OS, overall response rate, very good partial response (VGPR) or better rate, and complete response (CR) or better rate.
Eighty-five patients from CARTITUDE-4 and CARTITUDE-1 were included. After adjustment, patients in the cilta-cel group (effective sample size = 39) had a 58% reduction in PFS risk [hazard ratio (HR) 0.42 (95% CI 0.26-0.68); p = 0.0004] and a 42% reduction in OS risk [HR 0.58 (0.34-0.99); p = 0.0452] versus ide-cel. Patients in the cilta-cel group were significantly more likely to achieve an overall response [relative response ratio (RR) 1.22 (95% CI 1.08-1.38); p = 0.0126] and deeper levels of response [≥ VGPR: RR 1.37 (1.19-1.59); p = 0.0009; ≥ CR: RR 1.80 (1.49-2.18); p < 0.0001] versus ide-cel.
This updated MAIC with longer follow-up time demonstrated significant superiority of cilta-cel over ide-cel in PFS, OS, and response outcomes in patients with triple-class exposed RRMM treated with 2-4 prior LOT. The OS results reinforce the added value of cilta-cel in this population. TRIAL REGISTRATION: ClinicalTrials.gov ID: CARTITUDE-1: NCT03548207; CARTITUDE-4: NCT04181827; KarMMa-3: NCT03651128.
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