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Lisocabtagene maral...
Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: primary analysis of the phase 3 TRANSFORM study
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Abramson, JS (author)
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Solomon, SR (author)
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Arnason, J (author)
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Johnston, PB (author)
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Glass, B (author)
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Bachanova, V (author)
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Ibrahimi, S (author)
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- Mielke, S (author)
- Karolinska Institutet
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Mutsaers, P (author)
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Hernandez-Ilizaliturri, F (author)
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Izutsu, K (author)
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Morschhauser, F (author)
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Lunning, M (author)
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Crotta, A (author)
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Montheard, S (author)
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Previtali, A (author)
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Ogasawara, K (author)
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Kamdar, M (author)
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(creator_code:org_t)
- 2022-12-21
- 2023
- English.
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In: Blood. - : American Society of Hematology. - 1528-0020 .- 0006-4971. ; 141:14, s. 1675-1684
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http://kipublication...
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https://doi.org/10.1...
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Abstract
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- This global, phase 3 study compared lisocabtagene maraleucel (liso-cel) with standard of care (SOC) as second-line therapy for primary refractory or early relapsed (≤12 months) large B-cell lymphoma (LBCL). Adults eligible for autologous stem cell transplantation (ASCT) were randomized 1:1 to liso-cel (100×106 CAR+ T cells) or SOC (3 cycles of platinum-based immunochemotherapy followed by high-dose chemotherapy and ASCT in responders). The primary end point was event-free survival (EFS) by independent review. A total of 184 patients were randomized. In this primary analysis with a median follow-up of 17.5 months, median EFS was not reached (NR) for liso-cel versus 2.4 months for SOC (hazard ratio [HR] = 0.356; 95% confidence interval [CI]: 0.243‒0.522). Complete response (CR) rate was 74% for liso-cel versus 43% for SOC (P < .0001) and median progression-free survival (PFS) was NR for liso-cel versus 6.2 months for SOC (HR = 0.400; 95% CI: 0.261‒0.615; P < .0001). Median overall survival was NR for liso-cel versus 29.9 months for SOC (HR = 0.724; 95% CI: 0.443‒1.183; P = .0987). When adjusted for crossover from SOC to liso-cel, median overall survival was NR for liso-cel and SOC (HR = 0.415; 95% CI: 0.251‒0.686). Grade 3 cytokine release syndrome and neurological events occurred in 1% and 4% of patients in the liso-cel arm, respectively (no grade 4/5 events). These data show significant improvements in EFS, CR rate, and PFS for liso-cel over SOC and support liso-cel as a preferred second-line treatment compared with SOC in patients with primary refractory or early relapsed LBCL. (ClinicalTrials.gov; NCT03575351.)
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Blood
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- By the author/editor
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Abramson, JS
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Solomon, SR
-
Arnason, J
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Johnston, PB
-
Glass, B
-
Bachanova, V
-
show more...
-
Ibrahimi, S
-
Mielke, S
-
Mutsaers, P
-
Hernandez-Ilizal ...
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Izutsu, K
-
Morschhauser, F
-
Lunning, M
-
Crotta, A
-
Montheard, S
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Previtali, A
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Ogasawara, K
-
Kamdar, M
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show less...
- Articles in the publication
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Blood
- By the university
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Karolinska Institutet