Five-year survival outcomes of lisocabtagene maraleucel in R/R LBCL from the TRANSCEND NHL 001 study.

We present 5-year survival results in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) from TRANSCEND NHL 001 (TRANSCEND), including data from the separate long-term follow-up (LTFU) study. Overall, 345 patients were leukapheresed and 270 received lisocabtagene maraleucel (liso-cel). Among 257 patients who were efficacy-evaluable, median overall survival (OS) was 27.5 months (95% confidence interval [CI], 16.2-47.3; leukapheresed set: 15.2 months; 95% CI, 11.5-23.4); estimated 5-year OS was 38% (95% CI, 32-45; leukapheresed set: 33%; 95% CI, 28-39). Median disease-specific survival (DSS; excludes deaths unrelated to disease progression) was 67.8 months (95% CI, 23.5 to not reached [NR]; leukapheresed set: 27.4 months; 95% CI, 14.4-69.7]); estimated 5-year DSS was 52% (95% CI, 45-59; leukapheresed set: 47%; 95% CI, 41-52). Among patients from TRANSCEND who were efficacy-evaluable, alive at study completion, and enrolled in the LTFU (n = 84), median OS and DSS were NR (95% CI, NR to NR); estimated 5-year OS and DSS were 78% (95% CI, 67-86) and 92% (95% CI, 84-97), respectively. Most deaths occurred ≤2 years after infusion; no new safety signals were observed with low rates of late severe infections and second primary malignancies. These data support the curative potential of liso-cel in patients with R/R LBCL. This trial was registered at www.clinicaltrials.gov as NCT02631044 and NCT03435796.