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4870 Relinf Registry-Based Analysis Shows Overall Survival Improvement with New Therapies for Relapsed or Refractory Large B-Cell Lymphoma: A Study from the Geltamo Group

Program: Oral and Poster Abstracts
Session: 705. Cellular Immunotherapies: Late Phase and Commercially Available Therapies: Poster III
Hematology Disease Topics & Pathways:
Research, Biological therapies, adult, Lymphomas, Clinical Research, B Cell lymphoma, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Diseases, real-world evidence, Therapies, Lymphoid Malignancies, Study Population, Human
Monday, December 11, 2023, 6:00 PM-8:00 PM

Mariana Bastos-Oreiro, MD1*, Pau Abrisqueta Costa2*, Antonio Gutierrez3*, Ana Jimenez Ubieto4*, Maria Pozas, MD5*, Sonia Gonzalez De Villambrosia, MD6*, Raul Cordoba, MD, PhD7, Alberto Lopez Garcia, MD7, Elena Perez Ceballos8*, Belen Navarro9*, Ana Muntanola, MD PhD10*, Eva Donato, MD PhD11*, Eva Diez-baeza12*, Maria Lourdes Escoda Teigell13*, Hugo Daniel Luzardo Henriquez, MD14*, María Peñarrubia-Ponce15*, Daniel Garcia Belmonte, MD16*, Emilia Pardal17*, Claudia Lozada18*, Armando Lopez-Guillermo, MD PhD19 and Alejandro Martín García-Sancho20*

1Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
2Vall d'Hebron University Hospital, Barcelona, Spain
3Hematology Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain
4Hospital Universitario 12 de Octubre, MADRID, MADRID, Spain
5Hospital Universitario 12 de Octubre, Madrid, Spain
6IDIVAL/Valdecilla, Santander, Spain
7Fundacion Jimenez Diaz University Hospital, Madrid, Spain
8Hospotal Morales Meseguer, Murcia, ESP
9Hospital Puerta De Hierro, Madrid, ESP
10Hematology Department, Hospital Universitario Mutua de Terrassa, Terrassa, AL, ESP
11Hematology Department, Hospita Universitario Doctor Peset, Valencia, ESP
12Hospital Clínico Universitario de Salamanca, MD, Madrid, Spain
13Hospital Juan XXXIII, Instituto Catalán de la Salud, Tarragona, ESP
14Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain
15Hospital ClíNico Universitario De Valladolid, Valladolid, ESP
16Hematology Department, Hospital Universitario La Zarzuela, Madrid, Spain
17Hospital Virgen Del Puerto, Plasencia, ESP
18Instituto Valenciano de Oncología, Valencia, 46009, Spain
19Hospital Clínic de Barcelona, Barcelona, Spain
20Hematology Department, Hospital Universitario de Salamanca, IBSAL, CIBERONC, University of Salamanca, Salamanca, Spain

Introduction: Several new therapeutic agents have been approved in recent years for the treatment of relapsed/refractory (R/R) Large B cell lymphoma (LBCL) (diffuse large B cell lymphoma [DLBCL] and high-grade B cell lymphomas [HGBCL]), such as new monoclonal antibodies (MA), bispecific antibodies (BA) and CAR-T cell therapy. The objective of our study was to evaluate the epidemiology and the use of these new therapies (NT) in Spain and to analyze the impact on survival.

Methods: We present a multicenter retrospective study based on the GELTAMO (Spanish lymphoma group) RELINF platform. From 60 centers actively registering on the platform, 17 university hospitals accepted to participate, and 5 of them were CAR-T therapy providers. Participating centers completed a short questionnaire on disease relapse and the use of new drugs in their registered patients. The histologies included were DLBCL, HGBCL not otherwise specified (NOS), and double hit (DH).

Results: From 3270 patients with ABCL registered, 2853 patients were included in the present analysis; 738 patients experienced R/R disease, 492 (67%) were refractory or had early relapse (up to 1 year from the first line), and 246 (33%) late relapses, half of them (54%) during the second year. In both early and late relapse groups, about a third of patients were older than 80 years. Early relapses were significantly higher in double/triple hit HGL (34%) and T-cell-rich DLBCL (29%) compared to DLBCL or HGL NOS (16%) (p<0.001). The median number of lines among relapsed patients was 2 (1-10). 236 patients received NT, with the following distribution: CAR-T, n=144, BA, n=68, polatuzumab-based, n=92, and tafasitamab-lenalidomide, n=14. Most patients who received only 2 lines (n=376) were treated with conventional treatments, although 11 patients (3%) received CAR-T, 11 (3%) BM, 15 (4%) polatuzumab-based, and 5 (1%) tafasitamab-lenalidomide. Among 354 patients who received more than 2 lines of treatment, 130 (37%) received CAR-T cell therapy, 75 (21%) polatuzumab, 9 (2%) tafasitamab-lenalidomide, 55 (15%) BA, and 160 (45%) of these patients did not receive any NT. In the overall series, with a median follow-up of 49 months (95%CI: 47-51), median progression-free survival (PFS) was 54 months (95%CI: 48-61), and median overall survival (OS) was 82 months (95%CI: 74-90). Considering only the R/R patients, with a median follow-up of 40 months since the first relapse, the median OS2 (mOS2) was 16.8 (IC95%: 14.5-19) months. Survival analysis is shown in Table 1. The mOS2 for the early relapse group was 13.5 (95%CI: 11.5-15.5) months vs 31.1 (95%CI: 22.5-39.8) months for late relapses. Median OS2 for relapsed patients treated with NT was 31.1 months (95%CI: 22.5-39.7) compared with 11.9 months (95%CI: 9.2-14.6) for the group of standard treatment (p<0.001)) (Figure 1). Interestingly, OS2 was longer in patients treated in CAR-T provider centers than in non-CAR-T centers, in both early relapse group (mOS: 18.3 months [95%CI: 14.1-22.5] vs. 8.6 months [95%CI: 6.2-11]: p<0.001) and late relapse group (37.9 months [95%CI: 24.2-51.5] vs. 18.7 months [95%CI: 13.9-23.4], p=0.001). This difference was not found when we evaluated high complexity institutions (those that perform allogeneic transplant) vs. those that are no. In multivariate analysis, early relapse (HR 1.68, 95%CI 1.37-2.06, p<0.001), age over 65 years (HR 1.91, 95%CI: 1.23-2.98, p=0.004), treatment with CAR-T cell therapy (HR 0.68, 95%CI: 0.51-0.90, p=0.007) and treatment in a CAR-T cell provider center (HR 0.7, 95%CI: 0.58-0.85, p<0.001) independently influenced OS2.

Conclusions: Our real-world analysis confirms the negative impact on OS of factors like age or early relapse in patients with R/R LBCL. According to our results, the introduction in recent years of NT has markedly improved OS, especially CAR-T cell therapy.

Disclosures: Bastos-Oreiro: BMS, Kite, Novartis, F. Hoffmann-La Roche Ltd, Incyte, Abbvie: Honoraria, Speakers Bureau; F. Hoffmann-La Roche Ltd, Kite, SEHH, AMHH: Research Funding; Incyte, Kite: Consultancy; Gregorio Maranon Hospital: Current Employment, Membership on an entity's Board of Directors or advisory committees; SEHH, AMHH: Membership on an entity's Board of Directors or advisory committees. Cordoba: Fundacion Jimenez Diaz University Hospital: Current Employment; F. Hoffmann-La Roche Ltd, Takeda, Abbvie, Janssen, AstraZeneca, Lilly, BeiGene, BMS, Genmab, Incyte, Gilead: Consultancy; F. Hoffmann-La Roche Ltd, Takeda, Abbvie, Janssen, AstraZeneca, Lilly, BeiGene, BMS, Genmab, Incyte, Gilead: Speakers Bureau; European Hematology Association (EHA), Spanish Society Hematology (SEHH): Membership on an entity's Board of Directors or advisory committees. Lopez Garcia: Beigene: Consultancy; Roche: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Astrazeneca: Consultancy, Speakers Bureau. Lopez-Guillermo: F. Hoffmann-La Roche Ltd, Gilead/Kite, Genmab, Celgene, Abbvie: Consultancy; Gilead/Kite, F. Hoffmann-La Roche Ltd: Research Funding; F. Hoffmann-La Roche Ltd, Gilead/Kite: Honoraria; GELTAMO (Spanish group of lymphomas, chair), Spanish Society of Hematology (vice-chair): Membership on an entity's Board of Directors or advisory committees. Martín García-Sancho: Roche: Consultancy, Honoraria; BMS/Celgene: Consultancy, Honoraria; Kyowa Kirin: Consultancy; Novartis: Consultancy; Gilead / Kite: Consultancy, Honoraria; Incyte: Consultancy; Janssen: Honoraria; Lilly: Consultancy; Miltenyi: Consultancy; ADC Therapeutics America: Consultancy; Ideogen: Consultancy; Abbvie: Consultancy; Sobi: Consultancy, Honoraria; Takeda: Honoraria; Eusa Pharma: Honoraria.

*signifies non-member of ASH