Relmacabtagene Autoleucel Achieves Durable Responses With Manageable Safety For R/R FL: 2-Year Follow-Up From RELIANCE Study
Relmacabtagene autoleucel (relma-cel), demonstrated deep and durable responses with a favorable safety profile among patients with relapsed/refractory (R/R) follicular lymphoma (FL) treated after ≥3 prior lines of therapy, according to updated results from the phase 2 RELIANCE study published in the British Journal of Haematology.
Previous studies evaluating the efficacy of relmacabtagene autoleucel, a CD19-directed CAR T-cell therapy, have demonstrated significant clinical outcomes for patients with R/R FL who have had 3 or more prior lines of treatment. Researchers reported complete response rates (CRR) at 3-months in a 2-year follow-up.
The primary end points were duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety. Overall, 28 patients were included with a median age of 54 (range, 36 to 71) years. The median follow-up was 24.4 months and the 3-month CRR was 85.2%. The overall response rate (ORR) was 100%, and the median DOR and PFS were not reached. Additionally, the median OS was not reached, the estimated 2-year PFS was 80.3% and the estimated 2-year OS was 100%.
In terms of safety, the most common grade ≥ 3 treatment-emergent event was neutropenia which occurred in 39.3% of patients. No reports of cytokine release syndrome (CRS) were grade 3 or higher. Neurological toxicity grade ≥ 3 was reported in one patient treated with relmacabtagene autoleucel.
The researchers concluded, “Relma-cel demonstrated durable remissions and manageable safety without new safety signals during the 2-year follow-up in patients with R/R FL.”
Source:
Song Y, Zou D, Yang H, et al. Two‐year follow‐up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study. British Journal of Haematology. Published online September 1, 2025. doi:10.1111/bjh.20122
