ASH 2020 | ZUMA-9: expanded access protocol and OOS axicabtagene ciloleucel in R/R DLBCL
Frederick Locke, MD, Moffitt Cancer Center, Tampa, FL, outlines the results of the ZUMA-9 trial (NCT03153462) of out-of-specification or expanded access to axicabtagene ciloleucel (axi-cel) in relapsed/refractory large B-cell lymphoma patients. Following on from the finding of durable responses with axi-cel use in ZUMA-1, ZUMA-9 enrolled two trial arms: patients given expanded access to axi-cel until commercial availability (cohort 1) and patients treated with out-of-specification (OOS) products, most commonly due to low viability (cohort 2). The results showed axi-cel to be safe, and of clinical benefit in these cohorts, particularly in the expanded access arm. Compared to patients in cohort 1 and in ZUMA-1, cohort 2 patients had a notably lower overall and complete response rate. Consistent with this finding, median CAR-T cell expansion, and peak CAR T-cell levels were lower in cohort 2, and the final product had a higher proportion of differentiated cells. Enrolment and evaluation are ongoing. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
