Emergence of Novel Composite End Points Toxicity/PFS and Toxicity-Free CR to Benchmark Safety and Efficacy of CAR-T Cell Therapy for DLBCL
At the ASH 2025 Annual Meeting & Exposition, Veronika Bachanova, MD, PhD, University of Minnesota, Division of Hematology, Oncology and Transplantation, Minneapolis, Minnesota, elaborates on data on the potential value of novel composite end-points toxicity/progression-free survival (tfPFS) and toxicity-free complete remission (tfCR100) for evaluating the efficacy and safety of cell therapies for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
“The success of CAR-T is typically assessed by disease response and rates of immune complications like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Given the variability in both efficacy and of toxicity among available CD19 CAR-T products in relapsed/refractory large B-cell lymphoma, traditional outcomes may not fully capture the overall clinical impact of this therapy. Composite end-points may yield novel insights into net clinical benefit and optimal therapeutic index,” wrote Bachanova and coauthors.
“Our data reveal the emergence of novel tools that may be valuable in benchmarking cell therapies, health economic modeling, and guiding future strategies to optimize both safety and efficacy of CAR-T therapy,” they concluded.
Source:
Bachanova V, Cao Q, Hu M, et al. Novel composite end-points toxicity/progression-free survival (tfPFS) and toxicity-free complete remission (tfCR100) after CAR-T cell therapy for diffuse large B cell lymphoma: Cell therapy consortium analysis.. Dec 6-9, 2025; Orlando, FL. Abstract: 400
