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5170 Efficacy and Safety of Glofitamab in Patients with R/R DLBCL in Real Life Setting – a Retrospective Study

Program: Oral and Poster Abstracts
Session: 905. Outcomes Research—Lymphoid Malignancies: Poster III
Hematology Disease Topics & Pathways:
Biological therapies, Lymphomas, Bispecific Antibody Therapy, B Cell lymphoma, Diseases, aggressive lymphoma, Therapies, Lymphoid Malignancies
Monday, December 11, 2023, 6:00 PM-8:00 PM

Ronit Gurion, MD1,2*, Dmitri Guz, MD2,3*, Meirav Kedmi, MD2,4*, Chava Perry, MD2,5*, Irit Avivi Mazza, MD2,6*, Netanel A. Horowitz, MD7,8*, Uri Abadi, MD2,9*, Anat Gafter-Gvili, MD10,11,12*, Pia Raanani, MD1,2, Neta Goldschmidt13,14*, Boaz Nachmias, MD14,15* and Shlomzion Aumann, MD14,15*

1Institute of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel
2Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
3Department of Medicine A, Beilinson Campus, Rabin Medical Center, Petach Tikva, Israel
4Division of Hematology and Bone Marrow Transplantation, The Chaim Sheba Medical Center, Ramat Gan, Israel
5BMT Unit, Tel Aviv Sourasky Medical Center and Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
6Hematology Division, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel
7The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel
8Department of Hematology and Bone Marrow Transplantation, Rambam Health Care Campus, Haifa, Israel
9Hematology Institute, Meir Medical Center, Kfar Saba, Israel
10Department of Medicine A, Beilinson Campus, Rabin Medical Center, Petah-Tikva, Israel
11Faculty of medicine, Tel Aviv University, Tel Aviv, Israel
12Hematology Institute, Davidoff Cancer Center, Rabin Medical Center, Petah-Tikva, Israel
13Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel
14Department of Hematology, Hadassah Medical Center, Jerusalem, Israel
15Hebrew University, Jerusalem, Israel

Introduction - Glofitamab is a CD20-directed CD3 T-cell engager that has recently been approved by the FDA for relapsed and refractory diffuse large B cell lymphoma (R/R DLBCL). The approval was based on a pivotal phase II study including 154 patients with a median of 3 lines of treatment (a third post chimeric antigen receptor T (CAR-T) cell therapy) demonstrating an overall response rate (ORR) and complete response (CR) rate of 52% and 39%, respectively1. However real-life data is still lacking. The present study was aimed to determine the efficacy and safety of glofitamab in real-life settings.

Methods -A retrospective multicenter study including consecutive patients aged 18 years and older with R/R DLBCL, treated through a national compassionate program with at least 1 dose of glofitamab, after failing at least three lines of therapy. The first patient was recruited in September 2020 till January 2023. Outcomes included ORR and CR, defined by the Lugano criteria; progression free survival (PFS) and overall survival (OS), defined from the day of obinutuzimab infusion until event; cytokine release syndrome (CRS) and immune effector cells-associated neurotoxicity syndrome (ICANS) were defined by the ASTCT consensus 2019. Risk factors for PFS and OS were identified by univariate and multivariate analyses, using logistic regression.

Results – A total of 35 patients treated in 6 Israeli centers, were included. Median age at the time of initiation of glofitamab was 67 years (59-74) and 66% of the patients were males. The median number of previous therapies was 5 (IQR, 4-6) and 83% received more than 3 previous lines of therapy. 43% were primary refractory, all but 3 received CAR-T cell therapy (91%) and 23% underwent autologous stem cell transplantation (Table 1). Median follow up was 34 months (IQR, 18-57). Outcomes: 34% achieved ORR with 14% achieving CR. Median PFS and OS was 2 (IQR, 1-6) and 4 months (IQR, 2-10), respectively (Figure 1). At the end of follow up - 12 (34%) patients survived, 21 died and 2 patients were lost to follow- up. Causes of death included disease progression in 15 patients and infections in 6. Treatment was discontinued earlier than 12 cycles in 86%, mostly due to progressive disease (76%), and 24% due to infections (3 – COVID-19; 3- bacterial). Adverse events included CRS in 37% - all grade 1-2. 2 patients developed grade 1 ICANS. In a multivariate analysis including age, male, bulky disease, elevated LDH and CRS, only male sex was found to be significant risk factor for PFS and OS (p=0.02, p=0.04 respectively).

Conclusions – In this real-life cohort of R/R DLBCL, glofitamab showed less efficacy than in the pivotal study. This might be due to the more heavily pretreated patients in our series with nearly all patients post CAR-T. Nevertheless, toxicity in our real-life analysis was better than reported in the pivotal study, supporting the role of glofitamab in R/R DLBCL patients.


  1. Dickinson et al. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. NEJM 2022;387:2220-31

Disclosures: Gurion: ABBVIE: Honoraria; TAKEDA: Honoraria; MEDISON: Honoraria; GILHEAD: Honoraria; NOVARTIS: Honoraria; ROCHE: Honoraria. Avivi Mazza: AbbVie: Honoraria. Horowitz: F. Hoffmann-La Roche Ltd: Research Funding; F. Hoffmann-La Roche Ltd: Honoraria. Raanani: Janssen: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Novartis: Consultancy, Research Funding. Nachmias: AbbVie, Medison, Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees.

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