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BSH 2023 | Primary analysis of the Phase III TRANSFORM study: liso-cel in second-line LBCL

Andrew Davies, MRCP, PhD, University of Southampton, Southampton, UK, discusses the results from a primary analysis of the Phase III TRANSFORM study (NCT03575351), which compared lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) with salvage chemotherapy followed by autologous stem cell transplantation (autoSCT) in second-line large B-cell lymphoma (LBCL). At a follow-up of 17.5 months, results demonstrated that patients receiving treatment with liso-cel had a superior progression-free and event-free survival (PFS; EFS). Liso-cel was safe, with low rates of cytokine release syndrome (CRS) and neurotoxicity observed in patients. This interview took place at the 63rd Annual Scientific Meeting of the British Society for Haematology (BSH) 2023, held in Birmingham, UK.

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Transcript (edited for clarity)

It’s been really great to present data from the TRANSFORM study and this is the primary analysis. So, the TRANSFORM study asked the question in patients with relapsed/refractory diffuse large B-cell lymphoma and other types of large cell lymphoma, within 12 months of completing anthracycline-based chemotherapy, whether standard of care with reinduction chemotherapy followed by consolidation with stem cell transplant, or with CAR-T cell therapy with liso-cel, which is a 41-BB based CAR-T cell, was better...

It’s been really great to present data from the TRANSFORM study and this is the primary analysis. So, the TRANSFORM study asked the question in patients with relapsed/refractory diffuse large B-cell lymphoma and other types of large cell lymphoma, within 12 months of completing anthracycline-based chemotherapy, whether standard of care with reinduction chemotherapy followed by consolidation with stem cell transplant, or with CAR-T cell therapy with liso-cel, which is a 41-BB based CAR-T cell, was better. The design was really simple. All the patients who were eligible, who were up to the age of 75 all underwent leukapheresis and they were randomized in a one-to-one basis to receive either the standard of care, or to have liso-cel. Those patients receiving liso-cel could have one cycle of bridging therapy. They went on to have treatment, and the primary endpoint was event-free survival. The primary outcome demonstrates with 17.5 months of follow-up, that there is a superiority in terms of event-free survival in favor of those patients who received the CAR-T, rather than those patients who received standard of care. Actually, many of the patients who progressed using the standard of care arm could go on and have crossover and go on to have the CAR-T cell treatment and 58 patients had a crossover. So, we recognize that event-free survival was superior in favor of the CAR-T, progression-free survival was superior in terms of the CAR-T and also complete response rates was also superior. There’s yet to demonstrate an improvement in overall survival, although there was a clear trend. Now giving CAR-T therapy was safe, there was a low rate of cytokine release syndrome, particularly low rates of severe cytokine release syndrome, a low rate of neurotoxicity, and actually very few patients had prolonged cytopenias and there were few patients who needed to have immunoglobulin replacement. We looked at the kinetics of the CAR-T cell expansion, and we saw that that mirrored the other lines when this has been looked at before. So, I think a really important study firmly cementing the role of CAR-T cell therapy in second line treatment for large cell lymphoma.

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