Lisocabtagene Maraleucel 对比标准治疗用于二线复发/难治性大 B 细胞淋巴瘤：随机 III 期 TRANSFORM 研究的 3 年随访

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.