Patients with relapsed or refractory follicular lymphoma treated in the third-line setting with a single infusion of the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel continued to show responses after 3 years, according to long-term follow-up results from the TRANSCEND FL trial presented at the 2025 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 467).
“We are seeing unprecedented response rates and durable remissions in patients whose follicular lymphoma had previously resisted multiple therapies,” said the principal trial investigator Sairah Ahmed, MD, Associate Professor of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center. “These 3-year results highlight not only the long-lasting benefit of CAR T-cell therapy, but also its favorable safety profile, offering real hope for patients facing this challenging disease.”
Study Methods
The pivotal open-label TRANSCEND FL trial showed high response rates and a favorable safety profile with lisocabtagene maraleucel for patients with relapsed or refractory follicular lymphoma.
Updated findings presented at this year's ASH meeting focused on the patients treated in the third line or beyond. This population of patients had received at least two prior lines of combination systemic therapy, including an anti-CD20 antibody and an alkylator. Patients who received subsequent therapy were excluded from the analysis starting from the time they initiated the new therapy.
A total of 107 patients were evaluable for safety at data cutoff, and 103 were evaluable for efficacy.
Updated Efficacy Findings
At a median of on-study follow-up of 41.5 months, the overall response rate was 97% (95% confidence interval [CI] = 92%–99%) and the complete response rate was 94% (95% CI = 88%–98%).
Medians continued to be not yet reached for time-to-event survival outcomes. At 36 months, the duration of response rate was 70% (95% CI = 60%–78%), the progression-free survival rate was 68% (95% CI = 58%–76%), the overall survival rate was 86% (95% CI = 78%–92%), and the time to next treatment was 75% (95% CI = 66%–83%).
Post-hoc analyses explored efficacy by progression within 24 months from first-line chemoimmunotherapy status and by prior exposure to bendamustine before leukapheresis. In patients whose disease progressed within 24 months, the overall response rate was 96% and the complete response rate was 95%, while in patients who did not experience progression within 24 months, the overall response rate was 98% and the complete response rate was 93%. At 3 years, the patients who did experience progression within 24 months had a duration of response rate of 60%, a progression-free survival rate of 58%, an overall survival rate of 82%, and a time-to-next treatment rate of 68%, whereas patients without progression in 24 months had rates of 82%, 80%, 91%, and 85%, respectively.
The overall response rate in patients with prior bendamustine exposure was 97% vs 98% in patients without bendamustine exposure; the complete response rates were 93% and 95% for patients with and without bendamustine exposure, respectively. At 3 years, the patients with prior bendamustine exposure had a duration of response rate of 70%, a progression-free survival rate of 68%, an overall survival rate of 81%, and a time-to-next treatment rate of 73%, whereas patients without bendamustine exposure had rates of 69%, 67.5%, 93%, and 78.5%, respectively.
Updated Safety Findings
No new safety signals were identified with lisocabtagene maraleucel at 3 years. Grade 3 cytokine-release syndrome was reported in 1% of patients, and there were no grade 4 or 5 events. Grade 3 neurological events were observed in 2%, with no grade 4 or 5 events. Twelve percent of patients had grade 3 or higher infections, which included three more patients since the 2-year follow-up analysis of the trial. Ten percent of patients developed a second primary malignancy, which accounted for four additional patients since the 2-year analysis; none of these included secondary T-cell malignancies. Incidences of grade 3 or higher neutropenia and hypogammaglobulinemia decreased over time.
Disclosure: The study was sponsored by Bristol Myers Squibb. For full disclosures of the study authors, visit hematology.org.
