Posted: Thursday, January 5, 2023
A study performed by Martin Dreyling, MD, of Ludwig Maximilian University Hospital of Munich, and colleagues evaluated tisagenlecleucel—a chimeric antigen receptor (CAR) T-cell therapy—in patients with relapsed or refractory follicular lymphoma. The 2-year follow-up data, presented during the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 608), revealed this agent demonstrated “robust” and durable responses more than 2 years after treatment, with a favorable safety profile.
This study enrolled 94 patients with relapsed or refractory follicular lymphoma who had received at least two prior therapy lines, including an anti-CD20 antibody or who had relapsed after autologous stem cell transplantation. Participants received single-dose tisagenlecleucel after lymphodepleting chemotherapy.
At a median follow-up of 28.9 months, the overall response rate was 86.2%, and the rate of complete response was 68%. The 24-month estimate of overall survival and durability of response rates were 64.6% and 87.7%, respectively. Progression-free survival was not reached. Although no new safety signals were observed, neurologic events were noted in 12 patients, and 3 participants died of progressive disease or serious adverse events (none were thought to be related to treatment).
It appeared that progression of disease within 2 years of initial treatment, elevated tumor burden at baseline, and more than four nodal areas at inclusion were all associated with lower efficacy. Additionally, baseline serum tumor necrosis factor-α and interleukin-10 levels correlated with tumor burden (P < .001). An increase in LAG3-positive exhausted T cells was associated with shorter progression-free survival (P = .0017), whereas decreased CD8-positive cytotoxic T cells and increased CD19-positive B cells were associated with a poor outcome, according to the investigators. In multivariate Cox models, progression of disease within 2 years of initial treatment, tumor infiltrated LAG3-positive CD3-positive cells, elevated tumor burden at baseline, and more than four nodal areas at inclusion significantly impacted progression-free survival.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
2022 ASH Annual Meeting and Exposition