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296 Real-Word Experience of CAR T-Cells in Patients with Relapsed/Refractory Follicular Lymphoma : A Descart Registry Analysis from the Lysa

Program: Oral and Poster Abstracts
Type: Oral
Session: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Prospective and Real-World Outcomes of Novel Therapies in Indolent Lymphomas and MCL
Hematology Disease Topics & Pathways:
adult, Clinical Practice (Health Services and Quality), Lymphomas, non-Hodgkin lymphoma, Diseases, indolent lymphoma, Lymphoid Malignancies, Study Population, Human
Saturday, December 9, 2023: 4:15 PM

Loic Ysebaert, MD, PhD1*, Roch Houot, MD, PhD2*, Olivier Casasnovas, MD3*, Choquet Sylvain4*, Fabrice Jardin, MD PhD5*, Michael Loschi, MD6*, Gabriel Brisou7*, Catherine Thieblemont, MD8*, Jacques-Olivier Bay, MD, PhD9*, Cristina Castilla-Llorente, MD10*, Tom Fradon11*, Steven Le Gouill, MD, PhD12, Franck Morschhauser, phd13,14, Guillaume Cartron, MD, Ph-D15* and Emmanuel Bachy, MD, PhD16*

1Hematology Department, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
2Clinical Hematology, INSERM U1236, EFS, Hopital Pontchaillou, Rennes University Hospital, Rennes, France
3Clinical Hematology, François Mitterand Hospital, Dijon, FRA
4Hopital de la Pitié Salpetrière, APHP, Paris, FRA
5Centre Henri-Becquerel and University of Rouen, Rouen, France
6Service d’hématologie, CHU de Nice, Nice, France
7Institut Paoli-Calmettes, Department of Hematology, Marseille Cedex 09, France
8Assistance Publique Des Hopitaux De Paris, Paris, FRA
9Service d’hématologie, CHU Clermont-Ferrand, Clermont-Ferrand, France
10Department of Hematology, Gustave Roussy Cancer Campus, Villejuif, France
11LYSARC, Lyon, France
12Hematology Department, Institut Curie, Paris, France
13Hôpital Claude Huriez, Lille, France
14University of Lille, Lille, FRA
15Clinical Hematology Department, Montpellier University Hospital Center, Montpellier, France
16Lyon-Sud Hospital Center, Pierre-Bénite, France

Background: Anti-CD19 CAR T-cells have revolutionized the treatment of aggressive B-cell non-Hodgkin lymphomas (NHL) by demonstrating durable responses. Although follow-up remain short, axicabtagene ciloleucel (axi-cel, ZUMA-5) and tisagenlecleucel (tisa-cel, ELARA) demonstrated promising complete response rates (CRR) of 86% and 69%, respectively, in phase II trials including relapsed or refractory (R/R) follicular lymphoma (FL).. Tisa-cel and axi-cel are now approved after at least 2 lines of systemic therapy by the FDA. Few real-word evidence (RWE) data have been reported so far.

Methods: Patients were eligible if aged >18 years, had FL histology (grade 1-3A) and had received at least 2 previous treatment lines for tisa-cel and 3 for axi-cel according to the French early access program label. From Dec 2021 to Jan 2023, a total of 112 patients were included in early access program by 21 French centers and in DESCAR-T registry (NCT04328298), among them 87 were infused with a CAR product. At the data cut-off on March 2023, 70 had at least 1 month of follow-up (FU) with PET-CT evaluation, and thus were considered for the safety and efficacy sets (62 tisa-cel and 8 axi-cel,).

Results: Patient and disease characteristics were as follows: 46 males (65.7%), median age 62 years (range: 34-79), 3 median prior lines of therapy (range 2-9, including bi-specific antibody in 12.9% and autoSCT in 44.3%), FLIPI 0-2 in 40.5% and 3-5 in 49.5%, bulky disease (>5cm) in 22%, and LDH > N 52.2%. POD24 after 1st systemic immunochemotherapy (IC) was reported in 44 patients (62.8%). Before CAR T-cell infusion, 58.6% of patients received a bridging therapy (20 (48.8%) chemotherapy, 25 (61%) monoclonal antibodies, 4 (9.8%) kinase inhibitors, 15 (36.6%) lenalidomide, and 3 (7.3%) radiotherapy). All patients but one received a fludarabine and cyclophosphamide-based lymphodepletion. Median time from order to infusion was 48 days (range 34-204), and 41 days (30-328) from leukapheresis to infusion.

Median FU was 7.3 months [6.4; 8.2] from product order, and 5.4 months [3.4; 6] from CAR infusion. Best ORR and CRR were 97.5 and 87.5%, respectively with 72.5% of patients in CR at 1 month with projected DOR and DOCR of 72.4% [56.8; 83.1%], and 79.7% [62.7%; 89.6%], respectively. Projected 6-months PFS, OS, were 71.8% [95% CI, 56.6%; 82.4%], 97.4% [83.2%; 99.6%], respectively. Fifteen (21.4%) patients progressed (median time from infusion to first relapse: 3 months (range 1-10 mo). Only one patient died from lymphoma progression.

Any-grade CRS and ICANS were reported for 74.3% and 27.1% of patients, but grade 3-4 CRS/ICANS were very unfrequent,1.4% and 4.3%, respectively. No grade 5 was reported. Persisting grade 3-4 hematologic toxicities at 1 and 3 months were: neutropenia (50% and 12.3%), thrombocytopenia (18.6% and 0%), and anemia (8.6% and 0%). Medically relevant bacterial and viral infections were reported in 20% and 14.3% of patients, respectively.

Conclusions: Although longer FU is needed to assess disease control, RWE data from the DESCAR-T registry confirm the excellent response rates and safety profile of CAR T-cells in R/R FL after at least 2 lines of previous therapy.

Disclosures: Ysebaert: Beigene: Honoraria, Research Funding, Speakers Bureau; Roche: Consultancy, Honoraria, Research Funding; AstraZeneca: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; BMS/Celgene: Consultancy, Honoraria; Abbvie: Honoraria, Research Funding, Speakers Bureau; Gilead/Kite: Consultancy, Honoraria. Houot: Kite/Gilead, Novartis, Incyte, Janssen, MSD, Takeda, F. Hoffmann-La Roche Ltd: Honoraria; Kite/Gilead, Novartis, Bristol-Myers Squibb/Celgene, ADC Therapeutics, Incyte, Miltenyi: Consultancy. Jardin: Janssen, Gilead, AbbVie, F. Hoffmann-La Roche Ltd, BMS, Takeda: Honoraria. Loschi: Abbvie: Honoraria; Alexion: Honoraria; Astra Zeneca: Honoraria; BMS Celgene: Honoraria; Gilead: Honoraria; GSK: Honoraria; Jazz: Honoraria; Novartis: Honoraria; Pfizer: Honoraria; Sanofi: Honoraria; Sobi: Honoraria; Takeda: Honoraria. Brisou: Novartis: Consultancy. Castilla-Llorente: Gilead/Kite: Consultancy, Other: Travel support; Nektar Therapeutics: Consultancy. Morschhauser: Incyte: Other: Advisory Board; Genmab: Consultancy, Other: Advisory Board; Janssen: Honoraria; Celgene: Other: Advisory Board; BMS: Consultancy, Other: Advisory Board; AbbVie: Consultancy, Other: Advisory Board; Epizyme: Other: Advisory Board; Novartis: Consultancy, Other: Advisory Board; Gilead: Consultancy, Other: Advisory Board; Roche: Consultancy, Honoraria, Other: Advisory Board. Cartron: Roche: Consultancy, Honoraria; Novartis: Honoraria; MabQi: Consultancy; MedxCell: Consultancy; Janssen: Honoraria; Gilead: Honoraria; Emercell: Consultancy; BMS: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Jansen, Gilead, Novartis, F. Hoffmann-La Roche Ltd, BMS, Abbvie: Honoraria; MedxCell, Ownards Therapeutics, MabQi, Emercell, F. Hoffmann-La Roche Ltd, BMS, Abbvie: Consultancy; MabQi, Ownards Therapeutics, Abbvie, Roche, Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Ownards Therapeutics: Consultancy. Bachy: Hospices Civils de Lyon Claude Bernard Lyon 1 University: Current Employment; Pfizer: Honoraria, Other: Personal Fees; Takeda: Honoraria; Novartis: Honoraria, Other: Personal Fees; Incyte: Honoraria; Bristol Myers Squibb: Honoraria, Other: Personal Fees, Research Funding; Amgen: Research Funding; Roche: Consultancy, Honoraria; Kite, a Gilead Company: Honoraria, Other: Personal Fees.

*signifies non-member of ASH