CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Comparative Effectiveness of Ciltacabtagene Autoleucel in CARTITUDE-4 Versus Real-World Physician's Choice of Therapy from the Flatiron Registry in Lenalidomide-Refractory Multiple Myeloma.
Comparative Effectiveness of Ciltacabtagene Autoleucel in CARTITUDE-4 Versus Real-World Physician's Choice of Therapy from the Flatiron Registry in Lenalidomide-Refractory Multiple Myeloma.
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Cilta-cel 延长了 TTNT，并在 PFS 和 OS 方面显示出相较于真实世界医生选择对来那度胺难治性 MM 有意义的延长。这些数据突显了 cilta-cel 作为暴露于蛋白酶体抑制剂和免疫调节药物的复发性、来那度胺难治性 MM 早期线患者的有效疗法的价值。
西达基奥仑赛（cilta-cel）已获批用于复发/难治性多发性骨髓瘤（RRMM）。在CARTITUDE-4研究（NCT04181827）中，cilta-cel在既往接受1-3线治疗（LOT）后的RRMM患者中，相较于泊马度胺、硼替佐米和地塞米松或达雷妥尤单抗、泊马度胺和地塞米松，显示出更优的疗效。我们进行了一项间接治疗比较，以了解cilta-cel与真实世界（RW）医生选择的治疗方案在来那度胺难治性MM中的比较疗效。
来自Flatiron Health MM队列登记处（2020年1月至2024年5月）的去标识化数据与CARTITUDE-4的数据（数据截止日期为2024年5月1日）进行了比较。采用CARTITUDE-4的关键入组标准从Flatiron数据库中匹配患者。使用逆概率治疗加权对具有预后意义的基线协变量进行了调整。比较有效性结局包括无进展生存期（PFS）、真实世界PFS（RW PFS）、至下次治疗时间（TTNT）和总生存期（OS）。进行了敏感性分析。
CARTITUDE-4 队列包括 208 例接受 cilta-cel 治疗的患者数据；中位随访时间为 33.6 个月。真实世界队列包括来自 Flatiron 数据库的 932 例患者（1445 个符合条件的 LOT）；中位随访时间为 23.6 个月。在基础病例分析中，与 Flatiron 队列相比，接受 cilta-cel 治疗的患者 PFS 改善（风险比 [HR] 0.29 [95% 置信区间 (CI)] 0.22-0.36；p < 0.001）、RW-PFS 改善（HR 0.29 [95% CI 0.23-0.37]；p < 0.001）、TTNT 改善（HR 0.32 [95% CI 0.25-0.41]；p < 0.001），以及 OS 改善（HR 0.59 [95% CI 0.41-0.84]；p = 0.003）。这些发现在所有敏感性分析中均一致。
De-identified data from the Flatiron Health MM cohort registry (January 2020 to May 2024) were compared with data from CARTITUDE-4 (data cutoff May 1, 2024). Key eligibility criteria for CARTITUDE-4 were used to match patients from the Flatiron database. Baseline covariates of prognostic significance were adjusted using inverse probability of treatment weighting. Outcomes for comparative effectiveness included progression-free survival (PFS), RW PFS, time to next treatment (TTNT), and overall survival (OS). Sensitivity analyses were conducted.
The CARTITUDE-4 cohort included data from 208 patients who received cilta-cel; the median follow-up was 33.6 months. The real-world cohort included 932 patients (1445 eligible LOT) from the Flatiron database; the median follow-up was 23.6 months. In base case analyses, compared with the Flatiron cohort, patients treated with cilta-cel had improved PFS (hazard ratio [HR] 0.29 [95% confidence interval (CI)] 0.22-0.36; p < 0.001), RW-PFS (HR 0.29 [95% CI 0.23-0.37]; p < 0.001), TTNT (HR 0.32 [95% CI 0.25-0.41]; p < 0.001), and OS (HR 0.59 [95% CI 0.41-0.84]; p = 0.003). These findings were consistent across all sensitivity analyses.
Cilta-cel lengthened TTNT and demonstrated meaningful prolongation in PFS and OS compared with real-world physician's choice for lenalidomide-refractory MM. These data highlight the value of cilta-cel as an effective therapy in earlier-line patients with relapsed, lenalidomide-refractory MM exposed to proteasome inhibitors and immunomodulatory drugs. TRIAL REGISTRATION: CARTITUDE-4: ClinicalTrials.gov ID NCT04181827.
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