Posted: Wednesday, October 19, 2022
In a presentation at the 2022 Society of Hematologic Oncology (SOHO) Annual Meeting (Abstract EXABS-213-CT), Craig S. Sauter, MD, of the Cleveland Clinic, compared the standard of care—autologous platinum-based chemotherapy, high-dose therapy, and stem cell transplantation (HDT-ASCT)—with CD19-directed chimeric antigen receptor (CAR) T-cell therapy in the second-line treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). He concluded that since the cost of CAR T-cell therapy is taxing, the standard-of-care regimen may still be a viable option.
A total of three phase III studies challenged the standard-of-care regimen as second-line treatment of DLBCL: ZUMA-7 (axicabtagene ciloleucel), BELINDA (tisagenlecleucel), and TRANSFORM (lisocabtagene maraleucel). Both ZUMA-7 and TRANSFORM demonstrated a positive trend toward the primary endpoint in favor of CAR T cells, whereas the BELINDA study revealed a negative trend. Although these studies included patients with similar characteristics, there is still debate among the consideration of these regimens for standard care.
The ZUMA-7 trial favored axicabtagene ciloleucel over the standard of care, achieving median event-free survivals of 8.3 and 2 months, respectively. However, 80 patients enrolled in the standard-of-care arm elicited some type of response, and 62 individuals underwent HDT-ASCT. Since nearly a quarter of patients did not proceed to HDT-ASCT, it was suggested that cases of stable disease be reevaluated since patients with a partial response who also received HDT-ASCT had a cure fraction of approximately 50%.
The BELINDA trial was the only study to report a negative trend toward event-free survival. In light of a median event-free survival of 3 months in both treatment arms, Dr. Sauter suggested the prolonged time to infusion in the experimental arm and an additional “shot on goal” for the standard-of-care arm before crossing over may be responsible. In contrast, in the TRANSFORM study, lisocabtagene maraleucel improved 6-month event-free survival over standard care (63.3% vs. 33.4%). However, many patients in the experimental group underwent bridging therapy with salvage chemotherapy, potentially limiting the interpretation of this endpoint, according to Dr. Sauter.
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