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In TRANSFORM, a second CD19 CAR-T, lisocabtagene maraleucel, also beat chemotherapy-plus-transplant as second-line treatment, with a low rate of severe side effects.
TRANSFORM randomised 184 patients with large B-cell lymphoma refractory to or relapsed within 12 months of first-line therapy to lisocabtagene maraleucel (liso-cel) or standard salvage chemotherapy with autologous transplant for responders. Bridging chemotherapy was allowed and crossover to liso-cel was permitted for standard-arm failures. The primary endpoint was event-free survival. At the interim analysis median EFS was 10.1 versus 2.3 months (hazard ratio 0.35) with complete response 66% versus 39%; in the primary analysis median EFS was not reached versus 2.4 months (hazard ratio 0.36). Grade 3 CRS occurred in 1% and grade 3 neurological events in 4%. Overall survival was not significantly different, in part because of crossover.
TRANSFORM confirmed ZUMA-7's conclusion with a different CD19 CAR-T and a more permissive design that allowed bridging chemotherapy, making the results closer to real-world practice. Liso-cel's low toxicity makes it attractive for older or frailer patients and for outpatient delivery. Together the two trials made CAR-T the standard second-line therapy for early-relapsing aggressive lymphoma.
Shares BELINDA, TRANSFORM, Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study, Lisocabtagene maraleucel.
Shares BELINDA, TRANSFORM, Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study, Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma.
Shares BELINDA, TRANSFORM, Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma, ZUMA-7.
Shares Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma, ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early, ZUMA-7, CD19.
Shares BELINDA, TRANSFORM, ZUMA-7, ICANS (neurotoxicity).
Shares BELINDA, Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma, ICANS (neurotoxicity), Cytokine release syndrome (CRS).
Shares Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study, ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early, ZUMA-7, ICANS (neurotoxicity).
Shares ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early, ZUMA-7, CD19, CAR-T cell therapy.