Titre :

Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study.

Auteur(s) :

Phillips, T. J. [Auteur]
University of Michigan Medical School [Ann Arbor]
Carlo-Stella, C. [Auteur]
Humanitas University [Milan] [Hunimed]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Bachy, E. [Auteur]
Hospices Civils de Lyon [HCL]
Crump, M. [Auteur]
Princess Margaret Hospital
Trněný, M. [Auteur]
General University Hospital in Prague [VFN]
Bartlett, N. L. [Auteur]
Washington University School of Medicine [Saint Louis, MO]
Zaucha, J. [Auteur]
Medical University of Gdańsk
Wrobel, T. [Auteur]
Wrocław Medical University
Offner, F. [Auteur]
Universitair Ziekenhuis Leuven [UZ Leuven]
Humphrey, K. [Auteur]
Roche Products Ltd
Relf, J. [Auteur]
Roche Products Ltd
Filézac De L'etang, A. [Auteur]
Hoffman-La Roche Ltd
Carlile, D. J. [Auteur]
Roche Products Ltd
Byrne, B. [Auteur]
Roche Products Ltd
Qayum, N. [Auteur]
Roche Products Ltd
Lundberg, L. [Auteur]
Hoffman-La Roche Ltd
Dickinson, M. [Auteur]
The Royal Melbourne Hospital

Titre de la revue :

J Clin Oncol

Nom court de la revue :

J Clin Oncol

Pagination :

JCO2302470

Date de publication :

2024-10-14

ISSN :

1527-7755

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Purpose: Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) have a poor prognosis. The phase I/II NP30179 study (ClinicalTrials.gov identifier: NCT03075696) evaluated glofitamab monotherapy in patients with ...
Lire la suite >Purpose: Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) have a poor prognosis. The phase I/II NP30179 study (ClinicalTrials.gov identifier: NCT03075696) evaluated glofitamab monotherapy in patients with R/R B-cell lymphomas, with obinutuzumab pretreatment (Gpt) to mitigate the risk of cytokine release syndrome (CRS) with glofitamab. We present data for patients with R/R MCL. Methods: Eligible patients with R/R MCL (at least one previous therapy) received Gpt (1,000 or 2,000 mg) 7 days before the first glofitamab dose (single dose or split over 2 days if required). Glofitamab step-up dosing was administered once a day on days 8 (2.5 mg) and 15 (10 mg) of cycle 1, with a target dose of 16 or 30 mg once every 3 weeks from cycle 2 day 1 onward, for 12 cycles. Efficacy end points included investigator-assessed complete response (CR) rate, overall response rate (ORR), and duration of CR. Results: Of 61 enrolled patients, 60 were evaluable for safety and efficacy. Patients had received a median of two previous therapies (range, 1-5). CR rate and ORR were 78.3% (95% CI, 65.8 to 87.9) and 85.0% (95% CI, 73.4 to 92.9), respectively. In patients who had received previous treatment with a Bruton tyrosine kinase inhibitor (n = 31), CR rate was 71.0% (95% CI, 52.0 to 85.8) and ORR was 74.2% (95% CI, 55.4 to 88.1). CRS after glofitamab administration occurred in 70.0% of patients, with a lower incidence in the 2,000 mg (63.6% [grade ≥2, 22.7%]) versus 1,000 mg (87.5%; grade ≥2, 62.5%) Gpt cohort. Four adverse events led to glofitamab withdrawal (all infections). Conclusion: Fixed-duration glofitamab induced high CR rates in heavily pretreated patients with R/R MCL; the safety profile was manageable with appropriate support.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

Date de dépôt :

2024-12-08T22:05:59Z
2025-01-08T08:59:58Z