Titre :

Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: primary analysis of phase 3 TRANSFORM study.

Auteur(s) :

Abramson, Jeremy S [Auteur]
Massachusetts General Hospital [Boston]
Solomon, Scott R [Auteur]
Arnason, Jon [Auteur]
Johnston, Patrick B [Auteur]
Mayo Clinic [Rochester]
Glass, Bertram [Auteur]
Helios Klinikum [Erfurt]
Bachanova, Veronika [Auteur]
University of Minnesota [Twin Cities] [UMN]
Ibrahimi, Sami [Auteur]
University of Oklahoma [OU]
Mielke, Stephan [Auteur]
Karolinska University Hospital [Stockholm]
Mutsaers, Pim [Auteur]
Erasmus University Medical Center [Rotterdam] [Erasmus MC]
Hernandez-Ilizaliturri, Francisco [Auteur]
Roswell Park Cancer Institute [Buffalo] [RPCI]
Izutsu, Koji [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Lunning, Matthew [Auteur]
University of Nebraska Medical Center
Crotta, Alessandro [Auteur]
Bristol-Myers Squibb Company
Montheard, Sandrine [Auteur]
Bristol-Myers Squibb Company
Previtali, Alessandro [Auteur]
Bristol-Myers Squibb Company
Ogasawara, Ken [Auteur]
Bristol-Myers Squibb [Princeton]
Kamdar, Manali [Auteur]
University of Colorado Anschutz Medical Campus [Aurora]

Titre de la revue :

BLOOD

Date de publication :

2022-12-22

ISSN :

1528-0020

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

This global phase 3 study compared lisocabtagene maraleucel (liso-cel) with a standard of care (SOC) as second-line therapy for primary refractory or early relapsed (≤12 months) large B-cell lymphoma (LBCL). Adults eligible ...
Lire la suite >This global phase 3 study compared lisocabtagene maraleucel (liso-cel) with a 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; N = 184) were randomly assigned in a 1:1 ratio to liso-cel (100 × 106 chimeric antigen receptor-positive 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). In this primary analysis with a 17.5-month median follow-up, median EFS was not reached (NR) for liso-cel vs 2.4 months for SOC. Complete response (CR) rate was 74% for liso-cel vs 43% for SOC (P < .0001) and median progression-free survival (PFS) was NR for liso-cel vs 6.2 months for SOC (hazard ratio [HR] = 0.400; P < .0001). Median overall survival (OS) was NR for liso-cel vs 29.9 months for SOC (HR = 0.724; P = .0987). When adjusted for crossover from SOC to liso-cel, 18-month OS rates were 73% for liso-cel and 54% for SOC (HR = 0.415). Grade 3 cytokine release syndrome and neurological events occurred in 1% and 4% of patients in the liso-cel arm, respectively (no grade 4 or 5 events). These data show significant improvements in EFS, CR rate, and PFS for liso-cel compared with SOC and support liso-cel as a preferred second-line treatment compared with SOC in patients with primary refractory or early relapsed LBCL. This trial was registered at www.clinicaltrials.gov as #NCT03575351.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365

Équipe(s) de recherche :

Innovation/évaluation des médicaments injectables

Date de dépôt :

2023-05-25T02:20:21Z
2023-10-25T11:47:13Z
2023-10-25T12:07:35Z