FDA Approves Liso-Cel for Relapsed/Refractory Follicular Lymphoma


Lisocabtagene maraleucel has been granted FDA approval for the treatment of patients with relapsed/refractory follicular lymphoma.

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  • The FDA has granted accelerated approval to lisocabtagene maraleucel (liso-cel; Breyanzi) for the treatment of patients with relapsed/refractory (R/R) follicular lymphoma after 2 prior lines of therapy.
  • Liso-cel led to a high percentage of patients achieving complete remission and these remissions appear to be long lasting.
  • The study showed particular promise for liso-cel as a treatment option for patients with relapsed/refractory follicular lymphoma who are receiving it as a second-line therapy.

The FDA has granted accelerated approval to liso-cel for R/R follicular lymphoma based on findings from the TRANSCEND FL trial (NCT04245839).1

In the study, liso-cel demonstrated high complete response rates and durable remissions among patients with high-risk R/R follicular lymphoma when given in the second line.

In a poster presented at the 2023 American Society of Hematology (ASH) Annual Meeting & Exposition, 89.8% of patients with follicular lymphoma who were treated with the CD19-targeted chimeric antigen receptor (CAR) T-cell therapy were likely to experience a sustained response at 12 months. 2 The progression-free survival (PFS) rate among these patients was 91.3% at 12 months. At median follow-ups of 16.8 months and 17.8 months, the median DOR and PFS were not reached.2

Lymphoma cells: © Dr_Microbe - stock.adobe.com

Lymphoma cells: © Dr_Microbe - stock.adobe.com

Looking at safety, the most common grade ≥ 3 treatment-emergent adverse events (AEs) were cytopenias. Neutropenia was the most common, as seen in 52% of patients. Twelve patients (52%) had cytokine release syndrome (CRS);however, none were grade 3 or greater. The median times to onset and resolution of CRS were 6 days (range, 2-9) and 3 days (range, 2-7), respectively.

Seventeen percent of patients (n = 4) experienced neurological events, 1 (4%) of which was deemed grade 3. The median times to onset and resolution of neurological events were 8.5 days (range, 6-11) and 2.5 days (range, 1-4), respectively. Tocilizumab (Actemra) or steroids were given to 13% of patients for CRS or neurological events.

“We have a response rate of 96%, [and] all the patients achieved complete response. The progression-free survival at 12 months was very high, around 82%, and all patients but 1 were alive at 12 months, which is a reasonable time to evaluate this patient given the data cutoff,” said Franck Morschhauser, MD, PhD, professor, hematology, University of Lille and Hospital Claude Huriez, and chair, Lymphoma Study Association, in an interview with Targeted OncologyTM.

About the TRANSCEND FL Trial

“The TRANSCEND FL study [was] in patients with relapsed or refractory follicular lymphoma in the second line with high risk for transplant. It was a pivotal multicohort trial evaluating liso-cel, a CD19 CAR T-cell [therapy], in relapsed or refractory follicular lymphoma,” added Morschhauser.

In the TRANSCEND FL trial, patients were pretreated with intravenous (IV) fludarabine at 30 mg/m2/day and IV cyclophosphamide at 300 mg/m2/day for 3 days. Liso-cel was then given to patients at a target dose of 100 x 106 CAR-positive viable T cells.3

Enrollment was open to patients with R/R FL who had received at least 1 prior line of anti-CD20 and alkylating agent therapy, as well as 1 previous line of systemic therapy. An ECOG performance status of 0 or 1, adequate organ function, and adequate vascular access for the leukapheresis procedure were all requirements.

Patients with central nervous system involvement, history of another primary malignancy, history of active human immunodeficiency virus, or history of uncontrolled infection were excluded from the study.

The primary end point of TRANSCEND FL was overall response rate, and secondary end points included CRR, DOR, PFS, overall survival, AEs, and pharmacokinetics.

1. FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma. US FDA. May 15, 2024. Accessed May 15, 2024. https://tinyurl.com/mvp4mrt3
2. Morschhauser F, Dahiya S, Palomba ML, et al. TRANSCEND FL: Phase 2 study primary analysis of lisocabtagene maraleucel as second-line therapy in patients with high-risk relapsed or refractory follicular lymphoma. Presented at: 2023 American Society of Hematology Annual Meeting & Exposition, December 9-12, 2023; San Diego, California. Abstract 602.
3. A study to evaluate the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL) (TRANSCEND FL). ClinicalTrials.gov. Updated November 30, 2023. Accessed March 29, 2024. https://clinicaltrials.gov/study/NCT04245839
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