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1031 Efficacy of CD19-Directed CAR T Cell Therapy in Patients with Primary or Secondary CNS Lymphoma – an Analysis of the EBMT Lymphoma WP and the Gocart Coalition

Program: Oral and Poster Abstracts
Type: Oral
Session: 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Cellular Therapy for Multiple Myeloma, B-cell Acute Lymphoblastic Leukemia and B Cell Lymphomas: Clinical Trial and Real World Evidence
Hematology Disease Topics & Pathways:
Research, Diseases, Therapies
Monday, December 11, 2023: 5:30 PM

Anna Ossami Saidy1*, Stephan Fuhrmann, MD2*, Christophe Peczynski, MSc3*, Ariane Boumendil4*, Eva Michel5*, Jacques-Emmanuel Galimard6*, Hervé Finel7*, Michael Daskalakis, MD8*, Urban Novak, MD9*, David Beauvais, MD10*, Peter Vandenberghe, MD, PhD11, Nicolaus Kröger12*, Ron Ram, MD13, Jürgen Finke, MD14, Matthias Stelljes, MD15, Gerald G. Wulf, MD16*, Wolfgang Andreas Bethge, MD17*, Malte von Bonin, MD18*, Gesine Bug, MD19*, Andrea Kuhnl20*, Jakob Passweg Sr.21*, Friedrich Stoelzel22, Bastian von Tresckow, MD23, Anna Maria Sureda Balari, MD, PhD24, Peter Dreger, MD25, Norbert Schmitz, MD26* and Bertram Glass, MD, PhD27*

1Helios Klinikum Berlin Buch, Berlin, Germany
2Praxis für Hämatologie und Onkologie Berlin Mitte, Berlin, DEU
3EBMT Paris study office / CEREST-TC, Hôpital Saint Antoine, Sorbonne University, Paris, France
4EBMT Lymphoma Working Party, Paris Office, Paris, FRA
5EBMT Paris Study Office Paris France, Paris, France
6EBMT ALWP Statistical Unit, Saint Antoine Hospital, Sorbonne University, Paris, Paris, France
7European Society for Blood and Marrow Transplantation, Paris, France
8University Hospital Bern, Inselspital, Bern, Switzerland
9Department of Medical Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
10CHU Lille, Infinite U1286, INSERM, Lille, FRA
11University Hospital Gasthuisberg, Leuven, Belgium
12Universitätsklinikum Hamburg-Eppendorf, Hamburg, Hamburg, AL, DEU
13BMT Unit, Tel Aviv (Sourasky) Medical Center, Tel Aviv, Israel
14Department of Medicine, Hematology-Oncology, University of Freiburg, Freiburg, Germany
15University of Muenster, Muenster, Germany
16Universitaetsklinikum Goettingen, Goettingen, Germany
17Department of Internal Medicine II, Hematology, Oncology, Clinical Immunology and Rheumatology, University Hospital Tuebingen, Tuebingen, Germany
18Department of Internal Medicine I, University Hospital, TU Dresden, Dresden, Germany
19Klinik fuer Innere Medzin III, Ulm, Germany
20King’s College Hospital NHS Foundation Trust, London, United Kingdom
21University Hospital | Basel, Basel, Switzerland
22Department of Internal Medicine II (Hematology/Oncology), University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany
23Department of Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital of Essen, University of Duisburg-Essen, Essen, Germany
24Institut Catala D'Oncologia, Barcelona, Spain
25University of Heidelberg, Heidelberg, Germany
26University Hospital Münster, Münster, DEU
27Klinik für Hämatologie und Zelltherapie, Helios Klinik Berlin-Buch, Berlin, Germany

Introduction: The prognosis of patients (pts) with relapsed or refractory (r/r) large B cell lymphoma (LBCL) and central nervous system (CNS) involvement is dismal. Standard treatment for pts with r/r LBCL are anti-CD19 chimeric antigen receptor T-cells (CART). Several reports with limited numbers of patients suggest that CART might also be an effective treatment for pts with CNS lymphoma. This EBMT registry study aimed at compiling data to investigate the potential of CART in pts with primary (PCNSL) or secondary CNS lymphoma (SCNCL).

Methods: Centers contributing to the EBMT database were asked for cases of PCNSL and SCNSL, treated with CART between 01/ 2018 and 07/ 2022. Reported pts were identified in the database, patient characteristics and pre-treatment retrieved, and major clinical endpoints analyzed. To calculate overall survival (OS) and progression-free survival (PFS) from date of CART infusion Kaplan Meier estimates were used, whereas cumulative incidence was used for relapse incidence (RI) and non-relapse mortality (NRM).

Results: 88 pts with PCNSL (n=10) or SCNSL (n=78) with complete information on major endpoints were analyzed. Median follow-up was 20.3 months [95% CI: 16-27]. Median age was 63 years (range 31-80), 52 pts (59%) were male. ECOG was ≥ 2 in 19 of 86 pts (22%). 41 of 65 pts (63%) had undergone ≥3 prior treatment lines, 56 of 82 pts (68%) were refractory to at least one previous line of chemotherapy. 29 of 86 pts (34%) had received autologous stem-cell transplantation (ASCT). Of 84 patients 68% were not in remission at time of CART, 8% were in complete remission (CR) and 24% in partial remission (PR). Information on disease status was missing for four patients. 49 pts were treated with axicabtagene ciloleucel, 39 pts received tisagenlecleucel. OS- and PFS-rates at 24 months were 47% [95% CI: 37-61] and 32% [CI: 23-45] for the whole cohort (figure 1). RI at 24 months was 58% [CI: 47-68], NRM 10% [CI: 4-19]. OS and PFS for pts in CR/PR were 58% [CI 40-85] and 51% [CI: 33-77]. For 57 pts not in remission at CART infusion OS and PFS were 42% [CI: 30-59] and 24% [CI: 14-39], respectively.

Conclusion: With a 47% OS rate at 24 months CART seem to be a very effective therapeutic option in heavily pre-treated r/r LBCL with CNS manifestation. These results compare favorably with those reported for conventional treatment including pts treated with ASCT. Indeed, these results are similar to those reported by real-world analyses of CART in LBCL without CNS manifestation (Bethge et al., 2021, Le Gouill et al., 2021). Based on these promising early results, we consider treatment with CART for pts with CNS involvement and r/r LBCL as the preferred treatment option.

Disclosures: Fuhrmann: BMS: Honoraria. Novak: BMS: Other: Advisory Board; Novartis: Other: Advisory Boards; Gilead: Other: Advisory Boards. Beauvais: BMS: Honoraria, Other: Advisory Board; Kite/Gilead: Honoraria, Other: Advisory Board. Vandenberghe: Celgene/BMS: Consultancy; Novartis: Consultancy; Kite, a Gilead Company: Consultancy, Other: Travel support; Janssen Biotech: Consultancy, Research Funding; Miltenyi Biotec: Consultancy; Gilead Sciences: Consultancy, Other: Travel Support; Pfizer: Research Funding. Kröger: Takeda: Consultancy; Sanofi: Honoraria; Kite: Honoraria; Neovii: Honoraria; BMS: Honoraria; Novartis: Honoraria, Research Funding; Jazz: Honoraria; Riemser: Research Funding; DKMS: Research Funding; Amgen: Research Funding; BMS: Research Funding. Ram: BMS, Takeda, Sanofi, Pfizer: Honoraria; Novartis: Honoraria, Research Funding; Gilead: Honoraria; MSD: Honoraria. Finke: Gilead Sciences: Current holder of stock options in a privately-held company; AbbVie: Current holder of stock options in a privately-held company; Roche: Current holder of stock options in a privately-held company; Riemser: Honoraria, Research Funding, Speakers Bureau; Neovii: Honoraria, Research Funding, Speakers Bureau; Medac: Honoraria, Research Funding. Wulf: Gilead: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau. von Bonin: BMS: Other: Advisory Board; Novartis: Other: Advisory Board; Janssen: Research Funding; Kite: Other: Advisory Board. Bug: BMS: Honoraria, Research Funding; Gilead: Honoraria, Research Funding; Pfizer: Honoraria; Novartis: Honoraria; Jazz: Honoraria, Research Funding. Kuhnl: Kite Gilead: Honoraria; BMS: Honoraria; Abbvie: Honoraria; Novartis: Honoraria, Research Funding. Stoelzel: Medscape: Consultancy, Honoraria, Other: travel support; medac GmbH: Consultancy, Honoraria, Other: travel support. von Tresckow: Gilead Kite: Consultancy, Other: Travel Support; Incyte: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Other: Travel Support, Research Funding; IQVIA: Consultancy; Miltenyi: Consultancy; Allogene: Consultancy; BMS/Celgene: Consultancy, Honoraria; Cerus: Consultancy; Roche: Consultancy, Honoraria, Other: Travel Support; Noscendo: Consultancy; Pentixapharm: Consultancy; Amgen: Consultancy; Pfizer: Consultancy; Takeda: Consultancy, Honoraria, Other: Travel Support, Research Funding; MSD: Consultancy, Honoraria, Other: Travel Support, Research Funding; AbbVie: Other: Travel Support; AstraZeneca: Honoraria, Other: Travel Support; Lilly: Consultancy, Honoraria, Other: Travel Support; Pierre Fabre: Other: Travel support. Sureda Balari: Astra Zeneca: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; MSD: Consultancy, Honoraria; BMS/Celgene: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria; Jannsen: Consultancy, Honoraria; Pierre Fabre: Consultancy, Honoraria; GenMab: Consultancy, Honoraria; Kite: Consultancy, Honoraria. Dreger: AbbVie: Consultancy, Honoraria; AstraZeneca: Consultancy, Honoraria; BeiGene: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Janssen: Honoraria; bluebird bio: Consultancy; Novartis: Consultancy, Honoraria; Miltenyi: Consultancy; Riemser: Honoraria; MD Kompetenz-Centrum Onkologie: Honoraria. Schmitz: BMS: Current holder of stock options in a privately-held company; Miltenyi: Other: Travel Support; Roche: Research Funding; Allogene: Honoraria, Other: Travel Support; Jansen: Research Funding; Astra Zeneca: Research Funding. Glass: Roche: Consultancy, Honoraria, Research Funding; Gilead/Kite: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Miltenyi: Consultancy, Honoraria; Lonca: Consultancy; Jazz: Consultancy.

*signifies non-member of ASH