CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Efficacy of CARVYKTI in CARTITUDE-4 versus other conventional treatment regimens for lenalidomide-refractory multiple myeloma using inverse probability of treatment weighting.
Efficacy of CARVYKTI in CARTITUDE-4 versus other conventional treatment regimens for lenalidomide-refractory multiple myeloma using inverse probability of treatment weighting.
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III期随机对照试验（RCT）CARTITUDE-4（NCT04181827）证明，对于既往接受过1至3线治疗（LOT[s]）、包括免疫调节剂和蛋白酶体抑制剂，且对来那度胺难治的复发/难治性多发性骨髓瘤（RRMM）患者，CARVYKTI（ciltacabtagene autoleucel；cilta-cel）优于daratumumab、pomalidomide和dexamethasone（DPd）以及pomalidomide、bortezomib和dexamethasone（PVd）。这些分析估计了cilta-cel与其他常见治疗方案之间的相对疗效，而目前尚无直接比较证据。
患者数据来自CARTITUDE-4、CASTOR、CANDOR和APOLLO RCT。使用逆概率治疗加权（IPTW）调整队列之间关键患者特征的不平衡。相对疗效通过总缓解率（ORR）、非常好的部分缓解或更好率（≥VGPR）和完全缓解或更好率（≥CR）的缓解率比（RRs）及95%置信区间（CIs）估计，并通过无进展生存期（PFS）的风险比（HRs）及95% CIs估计。探索了使用不同分析方法和额外协变量的敏感性分析。
IPTW后，各队列之间的关键特征平衡良好。与所有对照方案相比，cilta-cel在PFS（HRs：0.11-0.51）、≥VGPR（RRs：1.51-5.13）和≥CR（RRs：2.90-35.24）方面显示出统计学显著获益，并且在大多数对照方案中ORR也有统计学显著改善（RRs：1.22-1.90）。结果在敏感性分析中保持一致。
Cilta-cel 相较于其他常见治疗方案显示出获益，突显其有潜力成为既往接受过 1 至 3 线治疗的来那度胺难治性 RRMM 患者的新标准治疗选择。这些比较有助于证明 cilta-cel 在标准治疗可能与 DPd/PVd 不同的国家中具有更优的疗效。
Aim: The phase III randomized controlled trial (RCT) CARTITUDE-4 (NCT04181827) demonstrated superiority of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) over daratumumab, pomalidomide and dexamethasone (DPd) and pomalidomide, bortezomib and dexamethasone (PVd) for relapsed/refractory multiple myeloma (RRMM) patients who have received one to three prior line(s) of therapy (LOT[s]) including an immunomodulatory agent and a proteasome inhibitor, and are refractory to lenalidomide. These analyses estimate the relative efficacy between cilta-cel and other common treatment regimens, for which no direct comparative evidence is available. Materials & methods: Patient data were available from the CARTITUDE-4, CASTOR, CANDOR and APOLLO RCTs. Imbalances between cohorts on key patient characteristics were adjusted for using inverse probability of treatment weighting (IPTW).
Relative efficacies were estimated with response rate ratios (RRs) and 95% confidence intervals (CIs) for overall response rate (ORR), very good partial response or better rate (≥VGPR) and complete response or better rate (≥CR), and with hazard ratios (HRs) and 95% CIs for progression-free survival (PFS). Sensitivity analyses using different analytical methods and additional covariates were explored. Results: Key characteristics were well balanced across cohorts after IPTW. Cilta-cel showed statistically significant benefit in PFS (HRs: 0. 11-0. 51), ≥VGPR (RRs: 1.
51-5. 13) and ≥CR (RRs: 2. 90-35. 24) versus all comparators, and statistically significant improvements in ORR over most comparator regimens (RRs: 1. 22-1. 90). Results were consistent across sensitivity analyses.
Conclusion: Cilta-cel demonstrated benefit over other common treatment regimens, highlighting its potential to become a new standard of care option for lenalidomide-refractory RRMM patients with one to three prior LOT(s). These comparisons help to demonstrate the improved efficacy of cilta-cel in countries where the standard of care may differ from DPd/PVd.
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