肿瘤细胞治疗研究
英文原题：Comparison of Cilta-cel, an Anti-BCMA CAR-T Cell Therapy, Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma.
Comparison of Cilta-cel, an Anti-BCMA CAR-T Cell Therapy, Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma.
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。
Cilta-cel 在三重暴露的复发/难治性 MM 患者中，与真实世界疗法相比，显著改善了结局。
在单臂、1b/2期CARTITUDE-1研究中，ciltacabtagene autoleucel（cilta-cel），一种抗B细胞成熟抗原CAR-T 细胞疗法，在既往接受过免疫调节药物、蛋白酶体抑制剂和抗CD38单克隆抗体（三类暴露）的美国多发性骨髓瘤（MM）患者中显示出令人鼓舞的疗效。
使用抗CD38单克隆抗体（MAMMOTH）难治性美国患者数据集，识别符合CARTITUDE-1入组资格并随后接受非CAR-T 治疗的患者。CARTITUDE-1的意向治疗（ITT）人群包括接受血细胞分离术的患者（N = 113）；改良ITT（mITT）人群为接受cilta-cel的亚组（n = 97）。从MAMMOTH数据集中识别出相应人群：ITT人群（n = 190）和自治疗开始起47天内（中位血细胞分离至cilta-cel输注时间）无进展/死亡的mITT人群（n = 122）。使用1:1最近邻倾向评分匹配以控制选定的基线协变量，CARTITUDE-1 ITT和mITT人群中分别有95例和69例患者与MAMMOTH患者匹配。
在CARTITUDE-1与MAMMOTH的ITT队列中，观察到总缓解率（ORR；84% vs. 28% [P < .001]）改善，无进展生存期（PFS；风险比[HR]，0.11 [95%置信区间(CI)，0.05-0.22]）和总生存期（OS；HR，0.20 [95% CI，0.10-0.39]）延长。在CARTITUDE-1与MAMMOTH的mITT队列中观察到相似结果（ORR：96% vs. 30% [P < .001]；PFS：HR，0.02 [95% CI，0.01-0.14]；OS：HR，0.05 [95% CI，0.01-0.22]），并且在使用替代匹配方法时也观察到相似结果。
In the single-arm, phase 1b/2 CARTITUDE-1 study, ciltacabtagene autoleucel (cilta-cel), an anti-B-cell maturation antigen chimeric antigen receptor T-cell (CAR-T) therapy, showed encouraging efficacy in US patients with multiple myeloma (MM) who previously received an immunomodulatory drug, proteasome inhibitor, and anti-CD38 monoclonal antibody (triple-class exposed).
A dataset of US patients refractory to an anti-CD38 monoclonal antibody (MAMMOTH) was used to identify patients who would meet eligibility for CARTITUDE-1 and received subsequent non-CAR-T therapy. The intent-to-treat (ITT) population in CARTITUDE-1 included patients who underwent apheresis (N = 113); the modified ITT (mITT) population was the subset who received cilta-cel (n = 97). Corresponding populations were identified from the MAMMOTH dataset: ITT population (n = 190) and mITT population of patients without progression/death within 47 days (median apheresis-to-cilta-cel infusion time) from onset of therapy (n = 122). Using 1:1 nearest neighbor propensity score matching to control for selected baseline covariates, 95 and 69 patients in CARTITUDE-1 ITT and mITT populations, respectively, were matched to MAMMOTH patients.
In ITT cohorts of CARTITUDE-1 vs. MAMMOTH, improved overall response rate (ORR; 84% vs. 28% [P < .001]) and longer progression-free survival (PFS; hazard ratio [HR], 0.11 [95% confidence interval (CI), 0.05-0.22]) and overall survival (OS; HR, 0.20 [95% CI, 0.10-0.39]) were observed. Similar results were seen in mITT cohorts of CARTITUDE-1 vs. MAMMOTH (ORR: 96% vs. 30% [P < .001]; PFS: HR, 0.02 [95% CI, 0.01-0.14]; OS: HR, 0.05 [95% CI, 0.01-0.22]) and with alternative matching methods.
Cilta-cel yielded significantly improved outcomes versus real-world therapies in triple-class exposed patients with relapsed/refractory MM.
MEMBER ACCOUNT
登录成功会直接打开下一页。
