Please use this identifier to cite or link to this item: https://repository.monashhealth.org/monashhealthjspui/handle/1/50979
Title: Mosunetuzumab Safety Profile in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma: Clinical Management Experience From a Pivotal Phase I/II Trial.
Authors: Matasar M.;Bartlett N.L.;Shadman M.;Budde L.E.;Flinn I.;Gregory G.P.;Kim W.S.;Hess G.;El-Sharkawi D.;Diefenbach C.S.;Huang H.;To I.;Parreira J.;Wu M.;Kwan A.;Assouline S.
Monash Health Department(s): Haematology
Monash University - School of Clinical Sciences at Monash Health
Institution: (Matasar) Rutgers Cancer Institute of New Jersey and RWJBarnabas Health, New Brunswick, NJ, United States
(Bartlett) Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States
(Shadman) Fred Hutchinson Cancer Research Center, Seattle, WA, United States
(Budde) City of Hope National Medical Center, Duarte, CA, United States
(Flinn) Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, United States
(Gregory) Monash Health and School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia
(Kim) Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea
(Hess) University Cancer Center Mainz, University Medical School of the Johannes Gutenberg-University, Mainz, Germany
(El-Sharkawi) The Royal Marsden NHS Foundation Trust, London, United Kingdom
(Diefenbach) NYU Langone, New York City, NY, United States
(Huang) Hoffmann-La Roche Ltd, Mississauga, ON, Canada
(To, Wu, Kwan) Genentech, Inc., South San Francisco, CA, United States
(Parreira) F. Hoffmann-La Roche Ltd, Basel, Switzerland
(Assouline) Jewish General Hospital, McGill University, Montreal, QC, Canada
Issue Date: 11-Jan-2024
Copyright year: 2024
Publisher: Elsevier Inc.
Place of publication: United States
Publication information: Clinical Lymphoma, Myeloma and Leukemia. 24(4) (pp 240-253), 2024. Date of Publication: April 2024.
Journal: Clinical Lymphoma, Myeloma and Leukemia
Abstract: Background: Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody approved in Europe and the United States for relapsed/refractory (R/R) follicular lymphoma (FL) after >= 2 prior therapies. Material(s) and Method(s): We present interim safety data from the mosunetuzumab GO29781 (NCT02500407) phase I/II dose-escalation study in R/R non-Hodgkin lymphoma (NHL), focusing on FL. Result(s): Overall, 218 patients with R/R NHL, including 90 with R/R FL, received a median of eight 21-day cycles of intravenous mosunetuzumab with step-up dosing in Cycle (C) 1 (C1 Day [D] 1, 1 mg; C1D8, 2 mg; C1D15/C2D1, 60 mg; C3D1 and onwards, 30 mg). Cytokine release syndrome (CRS) was the most common adverse event (AE), occurring in 39.4% (NHL) and 44.4% (FL) of patients. Events occurred predominantly during C1 at the first loading dose; the majority were grade 1/2. CRS events were managed at the investigator's discretion with supportive care, steroids, and tocilizumab, based on protocol management guidelines. Immune effector cell-associated neurotoxicity syndrome was uncommon, reported in 0.9% (NHL) and 1.1% (FL) of patients. Neutropenia occurred in 27.5% (NHL) and 28.9% (FL) of patients (mostly grade 3/4) and could be effectively managed using granulocyte colony-stimulating factor. Tumor lysis syndrome occurred in 0.9% (NHL) and 1.1% (FL) of patients (all grade 3/4 with CRS; all resolved). Conclusion(s): Mosunetuzumab monotherapy as treatment for R/R B-cell NHL, including FL, was associated with low rates of severe AEs (including CRS) and is suitable for outpatient administration in the community setting. Adapted protocol guidance for the management of select AEs during mosunetuzumab treatment is included.Copyright © 2023 The Authors
DOI: http://monash.idm.oclc.org/login?url=https://dx.doi.org/10.1016/j.clml.2023.12.005
PubMed URL: 38195322 [https://www.ncbi.nlm.nih.gov/pubmed/?term=38195322]
URI: https://repository.monashhealth.org/monashhealthjspui/handle/1/50979
Type: Article
Subjects: B cell lymphoma
cytokine release syndrome
follicular lymphoma
tumor lysis syndrome
Type of Clinical Study or Trial: Clinical trial
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