Lisocabtagene Maraleucel Shows Continued Efficacy, Manageable Safety for Patients with R/R LBCL

2-Year Follow-Up from the TRANSCEND NHL 001 Trial

Lisocabtagene maraleucel continues to demonstrate high response rates, durable remissions, and a manageable safety profile among patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), suggests 2-year follow-up data from the TRANSCEND NHL 001 trial.

Initial key findings from this trial indicated the efficacy and safety of lisocabtagene maraleucel as a 3rd-line or later treatment among this patient population. Primary end points were adverse events, 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).

Succeeding the 2-year follow-up, patients could enroll in a separate study assessing long-term (≤15 years) safety and OS. Eligible participants included 270 lisocabtagene maraleucel-treated patients, with a median age of 63 years, and a median of 3 prior lines (range, 1 to 8) of systemic therapy. It was observed that 181 patients (67%) had chemotherapy-refractory LBCL. The median follow-up was 19.9 months.

Results demonstrated that in the 257 efficacy-evaluable patients, the ORR was 73% and CR rate was 53%. The median (95% confidence interval) DOR, PFS, and OS were 23.1 (8.6 to not reached), 6.8 (3.3 to 12.7), and 27.3 months (16.2 to 45.6), respectively. Additionally, the estimated 2-year DOR, PFS, and OS rates were 49.5%, 40.6%, and 50.5%, respectively. 

Within the 90-day treatment-emergent period, grade 3 to 4 cytokine release syndrome and neurological events occurred in 2% and 10% of patients, respectively. It was noted that the most common grade ≥3 adverse events in treatment-emergent and posttreatment-emergent periods, respectively, were neutropenia (60% and 7%) and anemia (37% and 6%).

Jeremy S. Abramson, MD, Lymphoma Program, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Massachusetts, et al concluded, “Liso-cel demonstrated durable remissions and a manageable safety profile with no new safety signals during the 2-year follow-up in patients with R/R LBCL.”

Source:

Abramson J, Palomba M, Gordon L, et al. Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001. Blood (2024) 143 (5): 404–416. doi: 10.1182/blood.2023020854