Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001.

Lisocabtagene maraleucel (liso-cel) demonstrated significant efficacy with a manageable safety profile as third-line or later treatment in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) in the TRANSCEND NHL 001 study. Primary end points were adverse events (AE), dose-limiting toxicities, and objective response rate (ORR) per independent review committee. Key secondary end points were complete response (CR) rate, duration of response (DOR), progression-free survival (PFS), and overall survival (OS). After 2-year follow-up, patients could enroll in a separate study assessing long-term (≤15 years) safety and OS. Liso-cel-treated patients (N=270) had a median age of 63 years (range: 18‒86), a median of 3 prior lines (range: 1‒8) of systemic therapy, and 181 (67%) had chemotherapy-refractory LBCL. Median follow-up was 19.9 months. In efficacy-evaluable patients (n=257), the ORR was 73% and CR rate was 53%. The median (95% confidence interval) DOR, PFS, and OS was 23.1 (8.6-not reached), 6.8 (3.3-12.7), and 27.3 months (16.2-45.6), respectively. Estimated 2-year DOR, PFS, and OS rates were 49.5%, 40.6%, and 50.5%, respectively. In the 90-day treatment-emergent period (N=270), grade 3‒4 cytokine release syndrome and neurological events occurred in 2% and 10% of patients, respectively. The most common grade ≥3 AEs in treatment-emergent and post- treatment-emergent periods, respectively, were neutropenia (60% and 7%) and anemia (37% and safety profile with no new safety signals during 6%). Liso-cel demonstrated durable remissions and a manageable 2-year follow-up in patients with R/R LBCL (ClinicalTrials.gov, NCT02631044; NCT03435796).