CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 vs Physician's Choice of Therapy in the Long-Term Follow-Up of POLLUX, CASTOR, and EQUULEUS Clinical Trials for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma.
Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 vs Physician's Choice of Therapy in the Long-Term Follow-Up of POLLUX, CASTOR, and EQUULEUS Clinical Trials for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma.
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Cilta-cel 显示出优于医生选择治疗的疗效，使其成为三药暴露复发/难治性多发性骨髓瘤患者的一种有前景的新治疗选择。
西达基奥仑赛（cilta-cel）是一种新药，正在单臂CARTITUDE-1试验（NCT03548207）中用于对免疫调节药物、蛋白酶体抑制剂和抗CD38单克隆抗体三类暴露的复发/难治性多发性骨髓瘤患者的研究。本研究的目的是评估西达基奥仑赛与医生选择治疗的比较疗效，因为尚未进行头对头试验。
为CARTITUDE-1构建了一个外部对照臂，其患者来自daratumumab三项临床试验（POLLUX、CASTOR和EQUULEUS）长期随访中符合CARTITUDE-1入组标准的患者。这些患者在停用研究药物后接受了医生选择的治疗。采用逆概率治疗加权使外部对照人群与CARTITUDE-1人群在重要基线特征上保持一致。评估了ORR、完全缓解或更好缓解率、PFS、至下次治疗时间和OS。进行了多项敏感性分析。
经过倾向评分加权后，各队列之间的基线特征具有可比性。与医生选择的治疗方案相比，接受cilta-cel治疗的患者显示出更好的结果：总缓解率（相对风险：2.95 [95% CI 2.27, 3.84; p < 0.0001]）、完全缓解或更好（相对风险：111.70 [95% CI 29.08, 429.06; p < 0.0001]）、无进展生存期（风险比[HR]：0.24 [95% CI 0.15, 0.37; p < 0.0001]）、至下次治疗时间（HR：0.14 [95% CI 0.09, 0.22; p < 0.0001]）以及总生存期（HR：0.21 [95% CI 0.13, 0.35; p < 0.0001]）。在所有敏感性分析中结果均一致。
Ciltacabtagene autoleucel (cilta-cel) is a novel agent being investigated in the single-arm CARTITUDE-1 trial (NCT03548207) for patients with relapsed or refractory multiple myeloma who are triple-class exposed to an immunomodulatory drug, proteasome inhibitor, and an anti-CD38 monoclonal antibody. The objective of this study was to evaluate the comparative efficacy of cilta-cel vs physician's choice of treatment, as no head-to-head trials have been conducted.
An external control arm for CARTITUDE-1 was created from patients in the long-term follow-up for three clinical trials of daratumumab (POLLUX, CASTOR, and EQUULEUS) who satisfied the eligibility criteria of CARTITUDE-1. These patients received physician's choice of treatment following the discontinuation of study drugs. Inverse probability of treatment weighting was used to align the external control and CARTITUDE-1 populations on important baseline characteristics. Overall response rate, complete response or better rate, progression-free survival, time to next treatment, and overall survival were assessed. Several sensitivity analyses were conducted.
After propensity score weighting, baseline characteristics were comparable between cohorts. Patients showed improved results with cilta-cel vs physician's choice of treatment: overall response rate (relative risk: 2.95 [95% confidence interval (CI) 2.27, 3.84; p < 0.0001]), complete response or better (relative risk: 111.70 [95% CI 29.08, 429.06; p < 0.0001]), progression-free survival (hazard ratio [HR]: 0.24 [95% CI 0.15, 0.37; p < 0.0001]), time to next treatment (HR: 0.14 [95% CI 0.09, 0.22; p < 0.0001]), and overall survival (HR: 0.21 [95% CI 0.13, 0.35; p < 0.0001]). Results were consistent across all sensitivity analyses.
Cilta-cel showed superior efficacy compared with physician's choice of treatment, making it a promising new treatment option for patients with triple-class exposed relapsed or refractory multiple myeloma.
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