Tisagenlecleucel Remains Promising for Follicular Lymphoma in Extended Trial Follow-Up

Primary analysis of the phase II ELARA trial previously reported encouraging efficacy and safety performance of tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed or refractory follicular lymphoma (FL). These results were from a median follow-up of 17 months in the trial, and longer-term findings were recently published in Blood.

“Tisagenlecleucel continued to demonstrate highly durable efficacy and a favorable safety profile in this extended follow-up of 29 months in patients with relapsed or refractory FL enrolled in ELARA,” summarized lead author Martin Dreyling, MD, of Ludwig-Maximilian-University Hospital, Munich, Germany.

The follow-up analysis included 97 adult patients with relapsed or refractory FL of grades 1 through 3A. These patients had relapsed after at least two prior lines of therapy with an anti-CD20 antibody and an alkylating agent or following autologous stem cell transplantation. In the trial, they received tisagenlecleucel infusion as 0.6×10⁸ to 6×10⁸ CAR-positive viable T cells. Bridging chemotherapy was permitted in the patients.

The cohort had a median follow-up of 29 months and did not reach median progression-free survival (PFS), duration of response (DOR), or overall survival (OS).

The estimated 24-month PFS rate in the cohort was 57.4%, the overall response rate was 86.2%, and the complete response (CR) rate was 68.1%. Among patients who achieved CR, the estimated 24-month DOR was 77.8% and the estimated 24-month OS was 87.7%.

“Low levels of LAG3⁺CD3⁺ exhausted T cells and higher levels of naïve CD8⁺ T cells were significantly associated with improved outcomes,” Dr. Dreyling noted regarding the efficacy findings.

No new safety signals or treatment-related mortalities were reported in this extended follow-up.

The study was sponsored and designed by Novartis Pharmaceuticals Corporation.

Reference

Dreyling M, Fowler NH, Dickinson M, et al. Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update. Blood. 2024;143(17):1713-1725. doi:10.1182/blood.2023021567