Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial

Health-related quality of life with lisocabtagene maraleucel vs standard of care in relapsed or refractory LBCL

“…In the TRANSFORM study, liso-cel demonstrated significantly improved efficacy over SOC in the primary end point of EFS, as well as in key secondary efficacy end points of CR rate and progression-free survival, as second-line therapy in patients with R/R LBCL. 12 HRQOL data were collected in the TRANSFORM study to assess the treatment benefits of liso-cel vs SOC from the patient's perspective through the entire sequence of treatments in each of the study arms (leukapheresis followed by bridging therapy, if needed, lymphodepletion, and liso-cel infusion in the liso-cel arm vs 3 cycles of salvage chemotherapy followed by HDCT and ASCT in responding patients in the SOC arm). These data are the first comparative analysis of HRQOL outcomes in patients receiving liso-cel infusion vs SOC as second-line therapy.…”

“…The liso-cel arm also demonstrated statistically significant improvement in key secondary end points of complete response (CR) rate (66.3% vs 39.1%; P < .0001) and progression-free survival (median 14.8 vs 5.7 months; P = .0001); the safety profile was consistent with that observed in third-line or later treatment for LBCL. 12 Patients with R/R, aggressive LBCL have reported compromised health-related quality of life (HRQOL) after receiving treatment. [13][14][15][16] Results of the TRANSCEND NHL 001 study showed short-and long-term improvements in HRQOL after liso-cel infusion in patients with R/R LBCL who had received ≥2 prior lines of treatment.…”

CAR T-Based Therapies in Lymphoma: A Review of Current Practice and Perspectives

“…Based on the outstanding results of pivotal trials, axi-cel, tisa-cel and liso-cel were tested against standard of care salvage chemotherapy followed by autologous stem cell transplantation (SOC) in three large multicenter phase 3 randomized trials, respectively: ZUMA-7 [ 41 ], BELINDA [ 42 ] and TRANSFORM [ 43 ]. Eligible patients had to have progressive disease or relapse within 12 months from initial immunochemotherapy completion.…”

CAR-T cells—Real-time experience applying CAR-T cells—What we have learned so far

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CD19-targeted chimeric antigen receptor-engineered (CAR)-T cells are novel therapies showing great promise for patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma, mantle cell lymphoma, and follicular lymphoma. EMA-approved and commercially available CAR-T cell products have been used successfully by qualified CAR-T cell centers worldwide and these real world data compare favorably to pivotal study results with overall response rates (ORR) and complete response rates (CR) ranging from 51-93% and 40-64%, respectively [1][2][3][4][5][6][7][8][9].Recently, axicabtagene ciloleucel (axi-cel) received FDA approval based on results of a multicenter, randomized study comparing axi-cel to conventional salvage chemoimmunotherapy and autologous blood stem cell transplantation (ASCT) as second-line treatment in patients with relapsed or refractory DLBCL [10,11]. After a median follow-up of 24.9 months, median event-free survival (EFS) was more than 4-fold greater and ORR was 33% higher with double the CR rate in the axi-cel arm.

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“…Recently, axicabtagene ciloleucel (axi-cel) received FDA approval based on results of a multicenter, randomized study comparing axi-cel to conventional salvage chemoimmunotherapy and autologous blood stem cell transplantation (ASCT) as second-line treatment in patients with relapsed or refractory DLBCL [10,11]. After a median follow-up of 24.9 months, median event-free survival (EFS) was more than 4-fold greater and ORR was 33% higher with double the CR rate in the axi-cel arm.…”