# Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

Source: https://onco.cc/key-papers/paper-elara-tisagenlecleucel-follicular-nat-med-2022/  
OnCo record `paper-elara-tisagenlecleucel-follicular-nat-med-2022` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A single infusion of reprogrammed immune cells cleared follicular lymphoma completely in about seven of ten heavily pretreated people, with no severe cytokine release syndrome at all.

## Summary

The primary prespecified interim analysis of a multinational phase 2 trial of tisagenlecleucel in adults with relapsed or refractory follicular lymphoma after two or more treatment lines, or relapsing after autologous stem-cell transplantation. The primary endpoint was the complete response rate.

At the 29 March 2021 data cut-off, 97 of 98 enrolled patients had received tisagenlecleucel, at a median follow-up of 16.59 months (interquartile range 13.8 to 20.21). The primary endpoint was met: in the 94-patient efficacy set the complete response rate was 69.1 per cent (95 per cent confidence interval 58.8 to 78.3) and the overall response rate 86.2 per cent (77.5 to 92.4). Within eight weeks of infusion, in the 97-patient safety set, cytokine release syndrome occurred in 48.5 per cent with no grade 3 or worse case, neurological events in 37.1 per cent with 3 per cent grade 3 or worse, and immune effector cell-associated neurotoxicity syndrome in 4.1 per cent with 1 per cent grade 3 or worse. There were no treatment-related deaths.

## Fields

- Kind: Key paper
- Last checked: 2026-10-01
- Also known as: ELARA; Fowler 2022
- Tags: lymphoma-evidence
- Journal: Nature Medicine
- Year: 2022
- DOI: 10.1038/s41591-021-01622-0
- Authors: Fowler NH, Dickinson M, Dreyling M, et al.
- Findings: The complete response rate was 69.1 per cent (95 per cent confidence interval 58.8 to 78.3) and the overall response rate 86.2 per cent (77.5 to 92.4) in the 94-patient efficacy set.; Cytokine release syndrome occurred in 48.5 per cent within eight weeks of infusion, with no grade 3 or worse case.; Neurological events occurred in 37.1 per cent, grade 3 or worse in 3 per cent; immune effector cell-associated neurotoxicity syndrome in 4.1 per cent.; There were no treatment-related deaths.; A previous pilot study of tisagenlecleucel in relapsed or refractory follicular lymphoma had reported a complete response in 71 per cent of patients.
- What it means: Chemotherapy-free cellular therapy for follicular lymphoma that has stopped responding, with a toxicity profile mild enough that the treatment is deliverable outside the largest centres.
- Caveats: Single-arm phase 2 with no comparator; the natural history of this population on other treatments is not measured here.; A primary interim analysis at a median follow-up of 16.6 months, which is short for a disease measured in decades; the durability question is answered by later updates.; 97 patients, so subgroup estimates including the early-progression group are imprecise.

## Sources

- Nature Medicine 2022: https://doi.org/10.1038/s41591-021-01622-0
- PubMed: https://pubmed.ncbi.nlm.nih.gov/34921238/
- Europe PMC: https://europepmc.org/article/MED/34921238

## Connected records

- roadmaps: [Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting](https://onco.cc/roadmaps/lymphoma-roadmap/)
- cancers: [Follicular lymphoma](https://onco.cc/cancers/follicular-lymphoma/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/)
- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [CD19](https://onco.cc/targets/cd19/)
- drugs: [Tisagenlecleucel](https://onco.cc/drugs/tisagenlecleucel/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- terms: [Complete response](https://onco.cc/terms/complete-response/), [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [ICANS (neurotoxicity)](https://onco.cc/terms/icans/), [POD24: progression of follicular lymphoma within two years, and why it changes the plan](https://onco.cc/terms/lymphoma-tx-pod24/)
- trials: [ELARA](https://onco.cc/trials/elara/), [ZUMA-5](https://onco.cc/trials/zuma-5/)
- people: [Catherine Thieblemont](https://onco.cc/people/catherine-thieblemont/), [Martin Dreyling](https://onco.cc/people/martin-dreyling/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/), [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/)
- journals: [Nature Medicine](https://onco.cc/journals/nature-medicine/)
- key papers: [Early relapse of follicular lymphoma after R-CHOP defines patients at high risk for death: an analysis from the National LymphoCare Study](https://onco.cc/key-papers/paper-casulo-pod24-follicular-lymphoma-jco-2015/)

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