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ELARA: 4-year follow-up of tisagenlecleucel in patients with R/R FL
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The phase II ELARA trial (NCT02500407) assessed the safety and efficacy of tisagenlecleucel, a CAR T-cell therapy, in patients with R/R FL after ≥2 prior lines of therapy.1 Based on results from this trial, tisagenlecleucel was approved for treatment of these patients by the EC and received priority review by the FDA. The Lymphoma Hub reported previously on outcomes from the ELARA trial (N = 97 infused). The 4-year follow-up results were presented at the 66th ASH Annual Meeting and Exposition by Thieblemont.1 The data cut-off was March 27, 2024, and study endpoints were CRR, PFS, OS, ORR, and safety.1 |
| Key learnings |
| At a median follow-up of 53 months, the CRR was 69.1%. Subgroup analysis suggests that most baseline high-risk disease characteristics (double-refractory disease, bulky disease, POD24, and high FLIPI) were not associated with inferior outcomes. |
| Median PFS was 53.3 months and 48-month PFS was 50.2%; median OS was not reached; 48-month OS was 79.3%; ORR was 66.1%. |
| No new safety signals have been reported since the last data cut-off. Grade ≥3 TEAEs occurred in 28.6% of patients. |
| Long-term follow-up data from the ELARA trial demonstrate robust, durable responses with a tolerable safety profile of tisagenlecleucel >4 years post infusion regardless of high-risk disease characteristics, supporting its use in patients with R/R FL. |
Abbreviations: CRR, complete response rate; EC, European Commission; FDA, U.S. Food and Drug Administration; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; POD24, progression of disease within 24 months from the start of first-line therapy; TEAE, treatment-emergent adverse event; R/R, relapsed/refractory.
- Catherine Thieblemont. Clinical outcomes of patients with high-risk relapsed/refractory follicular lymphoma treated with tisagenlecleucel: Phase II ELARA 4-year update. Poster#3034. 66th American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 7–10, 2024; San Diego, US.
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