Two‐year follow‐up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study

Relmacabtagene autoleucel (relma-cel) demonstrated significant clinical outcomes for ≥3 lines of treatment for relapsed or refractory (R/R) follicular lymphoma (FL) in the RELIANCE study. The primary end-point was the complete response rate (CRR) at 3 months. Key secondary end-points included the duration of response (DOR), progression-free survival (PFS), overall survival (OS) and frequency/severity of adverse events (AEs). Relma-cel-treated patients (N = 28) had a median age of 54 years (range: 36-71 years), and more than 60% of the patients received ≥3 lines of prior systemic therapies. The median follow-up was 24.4 months. As previously reported, in the primary analyses set (n = 27), the 3-month CRR was 85.2% and the 3-month overall response rate was 100.0%. The median DOR, PFS and OS were not reached. As updated in this article, the estimated 2-year PFS and OS rates were 80.3% and 100% respectively. During the 90-day treatment-emergent period (N = 28), no patients had cytokine release syndrome of grade ≥3, and neurological toxicity of grade ≥3 occurred in only one patient treated with 100 × 10⁶ chimeric antigen receptor T cells. Neutropenia (39.3%) was the most common grade ≥3 treatment-emergent adverse event. There were no AEs leading to death. Relma-cel demonstrated durable remissions and manageable safety without new safety signals during the 2-year follow-up in patients with R/R FL (ClinicalTrials.gov, NCT04089215).