Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma | NEJM - nejm.org

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Abstract

Background

The prognosis for patients with relapsed oregon refractory diffuse ample B-cell lymphoma (DLBCL) is poor. Glofitamab is simply a bispecific antibody that recruits T cells to tumor cells.

Methods

In the signifier 2 portion of a signifier 1–2 study, we enrolled patients with relapsed oregon refractory DLBCL who had received astatine slightest 2 lines of therapy previously. Patients received pretreatment with obinutuzumab to mitigate cytokine merchandise syndrome, followed by fixed-duration glofitamab monotherapy (12 cycles total). The superior extremity constituent was implicit effect according to appraisal by an autarkic reappraisal committee. Key secondary extremity points included duration of response, survival, and safety.

Results

Of the 155 patients who were enrolled, 154 received astatine slightest 1 dose of immoderate survey attraction (obinutuzumab oregon glofitamab). At a median follow-up of 12.6 months, 39% (95% assurance interval [CI], 32 to 48) of the patients had a implicit effect according to autarkic review. Results were accordant among the 52 patients who had antecedently received chimeric antigen receptor T-cell therapy (35% of whom had a implicit response). The median clip to a implicit effect was 42 days (95% CI, 42 to 44). The bulk (78%) of implicit responses were ongoing astatine 12 months. The 12-month progression-free endurance was 37% (95% CI, 28 to 46). Discontinuation of glofitamab owed to adverse events occurred successful 9% of the patients. The astir communal adverse lawsuit was cytokine merchandise syndrome (in 63% of the patients). Adverse events of people 3 oregon higher occurred successful 62% of the patients, with people 3 oregon higher cytokine merchandise syndrome successful 4% and people 3 oregon higher neurologic events successful 3%.

Conclusions

Glofitamab therapy was effectual for DLBCL. More than fractional the patients had an adverse lawsuit of people 3 oregon 4. (Funded by F. Hoffmann–La Roche; ClinicalTrials.gov number, NCT03075696.)

Funding and Disclosures

Supported by F. Hoffmann–La Roche.

Disclosure forms provided by the authors are disposable with the afloat substance of this nonfiction astatine NEJM.org.

This nonfiction was published connected December 11, 2022, astatine NEJM.org.

A data sharing connection provided by the authors is disposable with the afloat substance of this nonfiction astatine NEJM.org.

We convey the patients and their families; the survey coordinators and nurses and the representatives of the sponsor who were progressive successful information postulation and analysis; and Louise Profit, Ph.D., of Ashfield MedComms, an Inizio company, for aesculapian penning assistance with an earlier mentation of the manuscript.

Author Affiliations

From the Peter MacCallum Cancer Centre, Royal Melbourne Hospital, and the University of Melbourne, Melbourne, VIC (M.J.D.), and Prince of Wales Hospital and the University of New South Wales, Sydney (M. Hertzberg) — each successful Australia; Humanitas University and Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Humanitas Research Hospital (C.C.-S.), and Università degli Studi di Milano and Fondazione IRCCS Istituto Nazionale dei Tumori (P.C.) — each successful Milan; Université de Lille, Centre Hospitalier Universitaire (CHU) Lille, Unité Labellisée de Recherche 7365, Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), Centre Hospitalier Lyon Sud, Lyon (E.B.), and CHU de Montpellier, Centre National de la Recherche Scientifique, Unité Mixte de Recherche 5535, Montpellier (G.C.) — each successful France; Vall d’Hebron University Hospital (G.I.) and Institut Català d’Oncologia Hospitalet, Institut d’Investigació Biomèdica de Bellvitge (IDIBELL), Universitat de Barcelona (A.S.) — some successful Barcelona; the Allegheny Health Network Cancer Institute, Pittsburgh (C.K.); Uniwersytet Medyczny we Wrocławiu, Wroclaw, Poland (T.W.); Universitair Ziekenhuis Gent, Ghent, Belgium (F.O.); the First Faculty of Medicine, Charles University Hospital, Prague, Czech Republic (M.T.); National Taiwan University Hospital, Taipei (S.-J.W.); F. Hoffmann–La Roche, Basel, Switzerland (D.P.-C., L.L.); Roche Products, Welwyn Garden City, United Kingdom (J.R., M.D., E.C., K.H.); and Rigshospitalet, Copenhagen (M. Hutchings).

Dr. Dickinson tin beryllium contacted astatine [email protected] oregon astatine the Peter MacCallum Cancer Centre, 305 Grattan St., Melbourne, VIC 3000, Australia.