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In adults with aggressive lymphoma after at least two prior treatments, tisagenlecleucel produced responses in 52% and complete responses in 40%, most of which lasted.
JULIET was an international single-arm phase 2 trial of tisagenlecleucel in adults with relapsed or refractory DLBCL after two or more lines of therapy who were ineligible for or had relapsed after autologous transplant. Of 165 enrolled, 111 were infused; 93 were evaluable for efficacy at the primary analysis. The best overall response rate was 52% with complete response in 40%; among responders the estimated relapse-free survival at 12 months was 65% and median duration of response was not reached. Grade 3-4 cytokine release syndrome occurred in 22% and grade 3-4 neurological events in 12%, with no deaths attributed to the product. Bridging chemotherapy was allowed. It supported approval of tisagenlecleucel in DLBCL in 2018, the second CD19 CAR-T for this disease.
JULIET, with ZUMA-1, showed that CAR-T could rescue a substantial minority of adults with chemotherapy-refractory lymphoma and that complete responders often stay in remission. The lower toxicity of a 4-1BB construct and the option of bridging therapy made it usable in a broader population. The high drop-out between enrolment and infusion remains a lesson about turnaround time.
Shares BELINDA, ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma, Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma, ICANS (neurotoxicity).
Shares BELINDA, JULIET, ICANS (neurotoxicity), Objective response rate (ORR).
Shares BELINDA, Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma, ICANS (neurotoxicity), Cytokine release syndrome (CRS).
Shares ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma, ICANS (neurotoxicity), Objective response rate (ORR), Cytokine release syndrome (CRS).
Shares Tisagenlecleucel, Abramson Cancer Center, University of Pennsylvania, Cytokine release syndrome (CRS), Manufacturing cost and time for living and radioactive medicines.
Shares ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma, ICANS (neurotoxicity), Objective response rate (ORR), Cytokine release syndrome (CRS).
Shares Tisagenlecleucel, Abramson Cancer Center, University of Pennsylvania, ICANS (neurotoxicity), Cytokine release syndrome (CRS).
Shares Tisagenlecleucel, ICANS (neurotoxicity), Cytokine release syndrome (CRS), Manufacturing cost and time for living and radioactive medicines.