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Diffuse large B-cell lymphoma (DLBCL) is an aggressive subtype of B-cell non-Hodgkin lymphoma that results in poor outcomes for most patients with relapsed and chemotherapy-refractory disease.
Now, investigators have conducted an industry-sponsored, international, phase II trial of centrally manufactured anti-CD19 CAR-T cell therapy in 93 patients with relapsed or refractory DLBCL who were ineligible for, or who relapsed after, autologous stem cell transplantation.
The best overall response rate (the primary endpoint) was 52%; 40% of patients achieved complete response (CR), and 12% achieved partial remissions. At 1 year following documented response, relapse-free survival was 65%. Toxicities included grade 3–4 cytokine release syndrome (22%), neurotoxicity (12%), and cytopenias or infections.
Schuster SJ et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med 2018 Dec 1; [e-pub]. (https://doi.org/10.1056/NEJMoa1804980)
Comment
This trial confirms both the feasibility and efficacy of this novel cellular therapy and addresses a previously unmet clinical need in DLBCL. Management of the unique toxicities of CAR-T therapy is improving; no treatment-related deaths were observed in the study. An important challenge remains in bridging treatments for patients with rapidly progressing relapse and chemotherapy-refractoriness to be able to receive CAR-T, given the several weeks needed for patient screening, leukapheresis, and manufacture of the product. The durability of responses is encouraging, but longer follow-up will be needed to determine curability.