Lisocabtagene maraleucel 作为大 B 细胞淋巴瘤的二线治疗：3 期 TRANSFORM 研究的主要分析

This global phase 3 study compared lisocabtagene maraleucel (liso-cel) with a standard of care (SOC) as second-line therapy for primary refractory or early relapsed (≤12 months) large B-cell lymphoma (LBCL). Adults eligible for autologous stem cell transplantation (ASCT; N = 184) were randomly assigned in a 1:1 ratio to liso-cel (100 × 106 chimeric antigen receptor-positive T cells) or SOC (3 cycles of platinum-based immunochemotherapy followed by high-dose chemotherapy and ASCT in responders). The primary end point was event-free survival (EFS). In this primary analysis with a 17. 5-month median follow-up, median EFS was not reached (NR) for liso-cel vs 2. 4 months for SOC. Complete response (CR) rate was 74% for liso-cel vs 43% for SOC (P < .

0001) and median progression-free survival (PFS) was NR for liso-cel vs 6. 2 months for SOC (hazard ratio [HR] = 0. 400; P < . 0001). Median overall survival (OS) was NR for liso-cel vs 29. 9 months for SOC (HR = 0. 724; P = . 0987). When adjusted for crossover from SOC to liso-cel, 18-month OS rates were 73% for liso-cel and 54% for SOC (HR = 0. 415).

Grade 3 cytokine release syndrome and neurological events occurred in 1% and 4% of patients in the liso-cel arm, respectively (no grade 4 or 5 events). These data show significant improvements in EFS, CR rate, and PFS for liso-cel compared with SOC and support liso-cel as a preferred second-line treatment compared with SOC in patients with primary refractory or early relapsed LBCL. This trial was registered at www. clinicaltrials. gov as #NCT03575351.