Real-World Evidence in Large B-Cell Lymphoma

Dr. Shah discusses why real-world evidence (RWE) is particularly important in large B-cell lymphoma, where the three approved CAR T-cell products were evaluated in separate pivotal trials rather than direct head-to-head comparisons. He explains how RWE provides opportunities to compare outcomes across products and evaluate whether clinical trial findings remain applicable to patients treated in routine practice. In particular, real-world populations often include patients who would not have met clinical trial eligibility criteria because of poorer performance status, impaired renal function, low blood counts, or other clinical factors. Dr. Shah highlights data from the French DESCAR-T registry, the U.S. Lymphoma CAR-T Consortium, CIBMTR, and multicenter retrospective cohorts showing that CAR T-cell therapy has demonstrated reproducible response, toxicity, and durability outcomes outside clinical trials. He also notes that RWE has provided additional insight into differences in toxicity, including cytokine release syndrome and ICANS, helping clinicians consider how individual CAR T-cell products may be matched to specific patients and clinical circumstances.