Lisocabtagene maraleucel (liso-cel) showed high response rates and favorable safety in patients with relapsed or refractory follicular lymphoma (R/R FL), according to results from the open-label, pivotal TRANSCEND FL study published in Transplantation and Cellular Therapy.
The paper reports on three-year follow-up results in patients with third-line or later (3L+) FL, including efficacy, safety, and longitudinal safety analyses for key adverse events.
Patients in the TRANSCEND FL study received liso-cel after lymphodepleting chemotherapy (LDC). Bridging therapy was allowed with reconfirmation of PET-positive disease before LDC. The primary endpoint was overall response rate (ORR) per independent review committee by PET/CT using Lugano 2014 criteria. Secondary endpoints included complete response (CR) rate, duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.
At data cutoff (March 31, 2025), 107 patients with 3L+ FL received liso-cel and were evaluable for safety; 103 were efficacy evaluable. For the 103 efficacy evaluable patients, the response rates were as follows: ORR 97.1%, CR 94.2%, 36-month DOR 70.0%, 36-month PFS 67.9%, 36-month OS 86.2%.
Treatment-emergent (TE) AE rates were consistent with the primary and two-year followup analyses. Grade 3 cytokine release syndrome was reported in 1% (no grade 4/5) and grade 3 neurological events in 2% (no grade 4/5). SPMs were reported in 11 patients (10%; 4 additional patients since the two-year followup analysis; no secondary T-cell malignancies). Grade ≥ 3 infections were reported in 13 (12%) patients, including 7 (7%) in the TE period (≤ 90 days after infusion) and 8 (7%) in the post-TE period (3 more patients since the two-year analysis).
“In patients with 3L+ FL, a single infusion of liso-cel demonstrated remarkable efficacy, with durable responses and high three-year survival rates, regardless of POD24 status or prior bendamustine exposure,” the authors wrote.
No new safety signals were identified, according to the authors. “Grade ≥ 3 neutropenia and hypogammaglobulinemia decreased over time and severe infections remained low, further underscoring the favorable long-term safety profile of liso-cel in patients with 3L+ FL,” they wrote.
