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Pivotal phase III pivotal TRANSFORM of Breyanzi shows improved survival in large B-cell lymphoma.- BMS

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Published:12th Dec 2021
Bristol Myers Squibb announced the first disclosure of results from a prespecified interim analysis of the pivotal TRANSFORM study, a global, randomized, multicenter, Phase III study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL) compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus autologous hematopoietic stem cell transplant (HSCT).

Results show, at a median follow up of 6.2 months, Breyanzi significantly improved event-free survival (EFS) compared to standard of care, the study’s primary endpoint, with a median EFS of 10.1 months (95% CI: 6.1-NR) for Breyanzi and 2.3 months (95% CI: 2.2-4.3) for standard of care (HR: 0.349; p<0.0001), representing a 65% reduction in risk of efs events with breyanzi. the majority of patients (86%) treated with breyanzi achieved a complete or partial response, with 66% of patients achieving a complete response. in comparison, less than half (48%) of patients who received the standard of care achieved a response, and only 39% of these patients achieved a complete response (p><0.0001). median progression-free survival was significantly longer with breyanzi compared to standard of care (14.8 months vs. 5.7 months [hr: 0.406; p="0.0001])."></0.0001).></0.0001),>

Although overall survival data were not yet mature, the prespecified interim analysis showed a trend favoring Breyanzi compared with the standard of care (HR: 0.509, 95% CI: 0.258-1.004, p=0.0257). Breyanzi exhibited a manageable safety profile with very low rates of severe cytokine release syndrome (CRS) and neurologic events, and no new safety signals were observedin this second-line setting. In the trial, no Grade 4/5 CRS or neurologic events were reported. Any-grade CRS was reported in 49% of patients, with Grade 3 CRS reported in only one patient. Any-grade neurologic events were reported in 12% of patients treated with Breyanzi, with Grade 3 neurologic events reported in four patients (4%). The data will be presented in an oral session during the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #91) and has been selected for inclusion in the ASH Annual Meeting Press Program.

Condition: B Cell Lymphoma (NHL)
Type: drug

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