TRANSFORM Study: Long-Term Follow-Up of Liso-Cel in R/R LBCL

The TRANSFORM study (NCT03575351) is a global, randomized, open-label, Phase 3 trial evaluating lisocabtagene maraleucel (liso-cel; Breyanzi), an autologous, CD19-directed, 4-1BB CAR T-cell product, against standard of care (SOC) for adults with second-line relapsed or refractory large B-cell lymphoma (R/R LBCL). SOC consisted of chemotherapy followed by high-dose chemotherapy and autologous stem cell trasplant (HDCT + ASCT). Previous results showed liso-cel had superior, more durable efficacy than SOC.

Here, Manali Kamdar, MD, MBBS, University of Colorado Anschutz, presents results after an approximate 4-year median follow-up for patients in the liso-cel arm, combining data from the initial TRANSFORM trial and a subsequent long-term follow-up (LTFU) study (NCT03435796. A total of 184 patients were randomized (92 per arm) in TRANSFORM⁵. Sixty-seven patients who received liso-cel (43 from the liso-cel arm, 24 crossover from the SOC arm) enrolled in the LTFU study.

The combined data for the 92 patients randomized to the liso-cel arm demonstrated sustained clinical benefit:

• 48-month progression-free survival (PFS) rate: 52.2% (95% CI, 41.5%–62.8%)
• 48-month overall survival (OS) rate: 61.5% (95% CI, 51.2%–71.7%)
• Median PFS and OS: Both were not reached

The safety analysis from the LTFU study in the liso-cel arm showed no new safety signals compared with prior TRANSFORM reports, indicating a manageable safety profile. Only 2 patients experienced any grade adverse events (AEs; hypogammaglobulinemia and dyspnea), and 1 patient had a grade 3 or 4 AE (dyspnea). Notably, there were no second primary malignancies or serious infections observed, and no AEs led to death.

These long-term results confirm that liso-cel provides continued long-term clinical benefit with high PFS and OS rates, supporting its effectiveness and curative potential as a second-line treatment for R/R LBCL.

REFERENCE

Kamdar M, Solomon S, Arnason J, et al. Lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) for second-line relapsed or refractory large B-cell lymphoma (LBCL): First Results from long-term follow-up of TRANSFORM. Presented at: 67th ASH Annual Meeting; December 6–9, 2025; Orlando, Florida. Abstract 3710.