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In mantle cell lymphoma that had stopped responding to BTK inhibitors, a single CAR-T infusion produced responses in 93% of patients and complete remissions in two-thirds.
ZUMA-2 was a single-arm phase 2 study of KTE-X19 (brexucabtagene autoleucel), a CD19 CAR-T manufactured with removal of circulating tumour cells, in relapsed or refractory mantle cell lymphoma after up to five prior lines including a BTK inhibitor. Of 74 patients enrolled, 68 received the product. In the primary efficacy analysis of the first 60 treated patients the overall response rate was 93% and complete response 67%; estimated 12-month PFS was 61% and OS 83%. Grade 3 or higher CRS occurred in 15% and neurological events in 31%. It led to FDA approval in 2020, the first CAR-T for mantle cell lymphoma.
ZUMA-2 gave patients with BTK-inhibitor-refractory mantle cell lymphoma, who previously had a median survival under a year, a therapy with durable remissions in a substantial fraction. Brexu-cel is now standard after BTK inhibitor failure and CAR-T is being tested earlier in the disease. Neurotoxicity rates are higher than in other lymphoma CAR-T trials.
Shares Michael L. Wang, Brexucabtagene autoleucel, Gilead Sciences (incl. Kite), Mantle cell lymphoma.
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 Michael L. Wang, BTK (Bruton tyrosine kinase), Ibrutinib, Mantle cell lymphoma.
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 Brexucabtagene autoleucel, Gilead Sciences (incl. Kite), Mantle cell lymphoma.
Shares ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma, ICANS (neurotoxicity), Gilead Sciences (incl. Kite), Cytokine release syndrome (CRS).
Shares ICANS (neurotoxicity), Gilead Sciences (incl. Kite), Cytokine release syndrome (CRS), CD19.
Shares ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma, MD Anderson Cancer Center, CD19, CAR-T cell therapy.