复发/难治性多发性骨髓瘤中标准治疗药物idecabtagene vicleucel与cilta-cabtagene autoleucel的比较。
Comparison of Standard-of-Care Idecabtagene Vicleucel and Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma.
作者信息
Hansen Doris K, Peres Lauren C, Dima Danai, Richards Alicia, Shune Leyla, Afrough Aimaz, Midha Shonali, Dhakal Binod, Kocoglu Mehmet H, Atrash Shebli, Ferreri Christopher, Castaneda Omar, Davis James A, Bhurtel Evguenia, McGuirk Joseph, Wagner Charlotte, Bansal Radhika, Costello Patrick, Smith Kinaya, Lieberman-Cribbin Alex, De Avila Gabriel, Purvey Sneha, Hosoya Hitomi, Mikkilineni Lekha, Oswald Laura B, Kaur Gurbakhash, Pasvolsky Oren, Gaballa Mahmoud, Herr Megan M, Forsberg Peter, Janakiram Murali, Htut Myo, Asoori Maringanti Sireesha, Kalariya Nilesh, Hashmi Hamza, Reshef Ran, Sborov Douglas W, Nadeem Omar, Anwer Faiz, Khouri Jack, Raza Shahzad, Atanackovic Djordje, Alsina Melissa, Freeman Ciara L, Locke Frederick L, Voorhees Peter, Anderson Larry D, Richard Shambavi, Martin Thomas, Lin Yi, Patel Krina K, Sidana Surbhi
机构信息
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
University of Washington Fred Hutchinson Cancer Center, Seattle, WA.
出版信息
J Clin Oncol. 2025 May;43(13):1597-1609. doi: 10.1200/JCO-24-01730. Epub 2025 Feb 18.
PURPOSE
Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), two B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapies have demonstrated remarkable efficacy in relapsed/refractory multiple myeloma (RRMM). We compare safety, efficacy, and survival among patients with RRMM treated with standard-of-care (SOC) ide-cel or cilta-cel.
METHODS
Data were from a retrospective chart review of patients with RRMM leukapheresed by December 31, 2022, with the intent to receive SOC ide-cel or cilta-cel at 19 institutions. An inverse probability of treatment weighting (IPTW) approach was used to compare outcomes by therapy type.
RESULTS
A total of 641 patients were leukapheresed by December 31, 2022, with ide-cel (n = 386) and cilta-cel (n = 255). Five hundred eighty-six patients were infused (n = 350 for ide-cel; n = 236 for cilta-cel) with a median follow-up of 12.6 and 13.0 months for ide-cel and cilta-cel, respectively. After IPTW, patient characteristics were well balanced. Cilta-cel was associated with higher likelihood of grade ≥3 cytokine release syndrome (CRS; odds ratio [OR], 6.80 [95% CI, 2.28 to 20.33]), infections (OR, 2.03 [95% CI, 1.41 to 2.92]), second primary malignancies (OR, 1.77 [95% CI, 0.89 to 3.56]), and delayed neurotoxicity (OR, 20.07 [95% CI, 4.46 to 90.20]). Cilta-cel was also associated with better treatment responses (≥complete response: OR, 2.42 [95% CI, 1.63 to 3.60]), longer progression-free survival (hazard ratio [HR], 0.48 [95% CI, 0.36 to 0.63]), and longer overall survival (HR, 0.67 [95% CI, 0.46 to 0.97]). No associations were observed between therapy type and immune effector cell-associated neurotoxicity syndrome, any CRS, severe cytopenia at days 30 and 90, or nonrelapse mortality. We observed consistent findings when repeating the analyses restricting the ide-cel cohort to patients infused during the same time period as Food and Drug Administration approval for cilta-cel (≥March 2022).
CONCLUSION
Cilta-cel demonstrated superior efficacy and survival, with higher incidence of certain toxicities, compared with ide-cel.
目的
伊德凯达宾（idecabtagene vicleucel，ide-cel）和西达基奥仑赛（ciltacabtagene autoleucel，cilta-cel）这两种靶向B细胞成熟抗原的嵌合抗原受体（CAR）T细胞疗法在复发/难治性多发性骨髓瘤（RRMM）中已显示出显著疗效。我们比较了接受标准治疗（SOC）的ide-cel或cilta-cel治疗的RRMM患者的安全性、疗效和生存率。
方法
数据来自对2022年12月31日前进行白细胞单采的RRMM患者的回顾性病历审查，这些患者计划在19家机构接受SOC的ide-cel或cilta-cel治疗。采用治疗权重逆概率（IPTW）方法按治疗类型比较结局。
结果
截至2022年12月31日，共有641例患者进行了白细胞单采，其中接受ide-cel治疗的有386例，接受cilta-cel治疗的有255例。586例患者接受了输注（ide-cel组350例；cilta-cel组236例），ide-cel组和cilta-cel组的中位随访时间分别为12.6个月和13.0个月。经过IPTW后，患者特征得到了很好的平衡。cilta-cel与≥3级细胞因子释放综合征（CRS）的发生可能性更高相关（比值比[OR]，6.80[95%置信区间，2.28至20.33]）、感染（OR，2.03[95%置信区间，1.41至2.92]）、第二原发性恶性肿瘤（OR，1.77[95%置信区间，0.89至3.56]）以及延迟性神经毒性（OR，20.07[95%置信区间，4.46至90.20]）相关。cilta-cel还与更好的治疗反应（≥完全缓解：OR，2.42[95%置信区间，1.63至3.60]）、更长的无进展生存期（风险比[HR]，0.48[95%置信区间，0.36至0.63]）和更长的总生存期（HR，0.67[95%置信区间，0.46至0.97]）相关。未观察到治疗类型与免疫效应细胞相关神经毒性综合征、任何CRS、第30天和第90天的严重血细胞减少或非复发死亡率之间存在关联。当将ide-cel队列限制为与cilta-cel获得美国食品药品监督管理局批准的同一时间段（≥2022年3月）内输注的患者重复分析时，我们观察到了一致的结果。
结论
与ide-cel相比，cilta-cel显示出更好的疗效和生存率，但某些毒性的发生率更高。
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