Long-Term Outcomes of Tisagenlecleucel in Follicular Lymphoma

Treatment with tisagenlecleucel yielded robust responses with favorable safety for more than four years post-chimeric antigen receptor (CAR) T-cell infusion in patients with relapsed or refractory follicular lymphoma in the phase II ELARA trial.

The data were presented by Catherine Thieblemeont, MD, of the Service Hémato-Oncologie, Hôpital Saint- Louis, at the 66^th American Society of Hematology Annual Meeting & Exposition.

The study included 94 eligible patients who were infused with tisagenlecleucel with a median follow-up of 53 months (range, 46-62). Of them, 72.3% were refractory to two or more prior regimens, 66.0% had bulky disease, 64.9% had disease progression within two years of frontline systemic therapy, 60.6% had high Follicular Lymphoma International Prognostic Index (FLIPI), and 21.3% had high tumor burden.

The median progression-free survival (PFS) for all patients was 53.3 months (95% CI, 18.2-not evaluable [NE]) per independent review committee. The 48-month PFS rate was 50.2% in all patients and 66.1% in patients who achieved a complete response as their best overall response. The median overall survival (OS) was not reached, and 48-month OS in evaluable patients was 79.3%.

Of the patients, 32 (33%) had evaluable MRD data. Of those, 28 (87.5%) achieved MRD negativity at any time. Negative MRD was achieved by 24 of 29 (82.8%) evaluable patients at day 28, 14 of 18 (77.8%) at month three, 16 of 22 (72.7%) at month six, and 14 of 17 (82.4%) at month 12.

The authors also observed CAR transgene persistence for up to 1,680 days, with a median time to last quantifiable transgene level of 210 days (range, 13-1680).

“Correlative analyses suggest that most baseline high-risk disease characteristics (double-refractory disease, bulky disease, POD24, and high FLIPI) are not associated with inferior efficacy following tisagenlecleucel infusion in patients with relapsed or refractory follicular lymphoma,” Dr. Thieblemont and colleagues concluded.

Reference

Thieblemont C, Dreyling M, Dickinson MJ, et al. Clinical outcomes of patients with high-risk relapsed/refractory follicular lymphoma treated with tisangenlecleucel: phase 2 ELARA 4-year update. Abstract# 3034. Presented at the 66th American Society of Hematology Annual Meeting & Exosition. December 7-10, 2024; San Diego, California.