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

作者：Manali Kamdar, Scott R. Solomon, Jon Arnason, Patrick B. Johnston, Bertram Glaß, Veronika Bachanová, Sami Ibrahimi, Stephan Mielke, Pim Mutsaers, Francisco J. Hernandez‐Ilizaliturri, Koji Izutsu, Franck Morschhauser, Matthew A. Lunning, Victor A. Chow, Sandrine Montheard, Josu Santamaria, Silvia Colicino, K. OGASAWARA, Lara Stepan, Fei‐Fei Liu, Jeremy S. Abramson · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco-25-00399 · 被引用次数：39 · 研究领域：CAR-T cell therapy research、Lymphoma Diagnosis and Treatment、Immune Cell Function and Interaction

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 × 10 6 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.