Lisocabtagene Maraleucel Versus Standard of Care for Second-Line Relapsed/Refractory Large B-Cell Lymphoma: 3-Year Follow-Up From the Randomized, Phase III TRANSFORM Study.

IF 42.1 1区 医学 Q1 ONCOLOGY
Manali Kamdar, Scott R Solomon, Jon Arnason, Patrick B Johnston, Bertram Glass, Veronika Bachanova, Sami Ibrahimi, Stephan Mielke, Pim Mutsaers, Francisco Hernandez-Ilizaliturri, Koji Izutsu, Franck Morschhauser, Matthew Lunning, Victor A Chow, Sandrine Montheard, Josu Santamaria, Silvia Colicino, Ken Ogasawara, Lara Stepan, Fei Fei Liu, Jeremy S Abramson
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引用次数: 0

Abstract

We report 3-year follow-up results from TRANSFORM comparing lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) for second-line primary refractory/early relapsed (≤12 months) large B-cell lymphoma (LBCL). Adults eligible for autologous stem cell transplantation (N = 184) were randomly assigned 1:1 to liso-cel (100 × 106 chimeric antigen receptor-positive T cells) or SOC. Results are reported descriptively. With a median follow-up of 33.9 months, median (95% CI) event-free survival was 29.5 months (9.5 to not reached [NR]) for liso-cel versus 2.4 months (2.2 to 4.9) for SOC (hazard ratio [HR], 0.375; 95% CI, 0.259 to 0.542). Median progression-free survival was NR (12.6-NR) for liso-cel versus 6.2 months (4.3-8.6) for SOC (HR, 0.422; 95% CI, 0.279 to 0.639) with 36-month rates of 51% versus 26.5%. Median overall survival (OS) was NR for both arms (HR, 0.757; 95% CI, 0.481 to 1.191), with 66% of patients crossing over to receive liso-cel; 36-month OS rate was 63% for liso-cel versus 52% for SOC. OS HR (0.566 [95% CI, 0.359 to 0.895]) favored liso-cel when accounting for the treatment effect of crossover. Safety results were consistent with previous reports. At 3-year follow-up, liso-cel confirmed superior, more durable efficacy versus SOC with a favorable safety profile and no new safety signals. These data support liso-cel as an effective second-line treatment with curative potential for relapsed/refractory LBCL.

Lisocabtagene Maraleucel与标准护理治疗二线复发/难治性大b细胞淋巴瘤:来自随机III期转化研究的3年随访
我们报告了TRANSFORM的3年随访结果,比较了lisocabtagene maraleucel (liso-cel)与标准护理(SOC)治疗二线原发性难治性/早期复发(≤12个月)大b细胞淋巴瘤(LBCL)的疗效。符合自体干细胞移植条件的成人(N = 184)按1:1的比例随机分配到liso- cell (100 × 106嵌合抗原受体阳性T细胞)或SOC。描述性地报告结果。中位随访时间为33.9个月,liso-cel的中位无事件生存期(95% CI)为29.5个月(9.5至未达到[NR]),而SOC的中位无事件生存期为2.4个月(2.2至4.9)(风险比[HR], 0.375;95% CI, 0.259 ~ 0.542)。liso-cel的中位无进展生存期为NR (12.6-NR),而SOC的中位无进展生存期为6.2个月(4.3-8.6)(HR, 0.422;95% CI, 0.279 - 0.639), 36个月的发病率分别为51%和26.5%。两组的中位总生存期(OS)均为NR (HR, 0.757;95% CI, 0.481 - 1.191), 66%的患者交叉接受liso- cell;lso -cel的36个月OS率为63%,而SOC为52%。考虑到交叉的治疗效果,OS HR (0.566 [95% CI, 0.359 ~ 0.895])有利于liso-cel。安全性结果与先前的报告一致。在3年的随访中,与SOC相比,liso-cel证实了更持久的疗效,具有良好的安全性,没有新的安全信号。这些数据支持liso- cell作为一种有效的二线治疗方法,具有治愈复发/难治性LBCL的潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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