By: Kerri Fitzgerald
Researchers presented four-year follow-up data from the phase 2 ELARA study, showing that response to tisagenlecleucel continues to deepen in patients with follicular lymphoma (FL), with an estimated 48-month progression-free survival (PFS) rate of 50.2%.
Professor Catherine Thieblemont, of the Hôpital Saint-Louis in Paris, France, presented the results as part of the 18th International Conference on Malignant Lymphoma in Lugano, Switzerland.
The study included patients with relapsed or refractory FL who have received two or more lines of systemic therapy, including an anti-CD20 monoclonal antibody and alkylating agent; 97 patients received a single infusion of tisagenlecleucel.
As of March 27, 2024, after a median follow-up of 53 months, 94 patients were evaluable for efficacy outcomes.
Median overall survival (OS) was not reached; the 48-month OS rate was 79.3%.
Patients with high-risk disease experienced durable responses to treatment (48-month PFS and OS), including those with:
- Progression of disease within 24 months (45.5% and 80.8%, respectively)
- High Follicular Lymphoma International Prognostic Index scores (45.5% and 73.2%)
- Bulky disease (45.2% and 73.0%)
- Double refractory disease (52.8% and 83.7%)
- High tumor burden (23.2% and 65.5%)
A third of patients (n=31; 33%) had measurable residual disease (MRD) information available, and 28 (90%) achieved MRD negativity at any time point. MRD-negative status was seen in:
- 82% of patients (n=22/27) at 28 days
- 75% (n=12/16) at 3 months
- 69% (n=11/16) at 6 months
- 76% (n=13/17) at 1 year
The researchers reported no new safety concerns. Six patients (6.2%) experienced second primary malignancies. At data cutoff, 19 patients had died.
“Correlative analyses suggest that most baseline high-risk disease characteristics are not associated with inferior efficacy following tisagenlecleucel infusion in [patients] with [relapsed/refractory] FL,” the authors concluded.
The study is supported by Novartis Pharmaceuticals Corporation.
Reference
Thieblemont C, Dreyling M, Dickinson MJ, et al. Phase 2 ELARA trial 4-year update: clinical outcomes of tisagenlecleucel in patients (pts) with high-risk relapsed/refractory follicular lymphoma (R/R FL). Abstract #138. Presented at the 18th International Conference on Malignant Lymphoma; June 17-21, 2025; Lugano, Switzerland.
