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2356 Importance of Early Rescue and Relative Dose-Intensity in the Salvage Therapy with Tafasitamab-Lenalidomide in Diffuse Large B-Cell Lymphoma: Real-Life Study in Spain (GELTAMO)

Program: Oral and Poster Abstracts
Session: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I
Hematology Disease Topics & Pathways:
Combination therapy, Lymphomas, B Cell lymphoma, Diseases, Aggressive lymphoma, Treatment Considerations, Lymphoid Malignancies
Saturday, December 7, 2024, 5:30 PM-7:30 PM

Antonio Gutiérrez1*, Izaskun Zeberio2*, Pilar Martinez-Barranco3*, Francisco Javier Peñalver4*, Sandra Pérez5*, Daniel Morillo, MD6*, Xabier Mart N Martitegui7*, Concepción Nicolás8*, Ainara Ferrero9*, Ana Jiménez Ubieto10*, Mariana Bastos-Oreiro11,12*, Julio Dávila-Valls13*, Maria Victoria Calle Gordo, BMBS,14*, María Pérez Sala, MD15*, Guillermo Rodríguez Garcia16*, Aranzazu Alonso Alonso, MD17*, Ana Garcia Noblejas, MD, PhD18*, Diana Sanchez Arguello19*, Teresa Knight Asorey, MD20*, Maria Angeles Fernandez Fernandez21*, Javier López Marin, MD22*, Jaime Perez de Oteyza23,24*, Sonia González De Villambrosia25*, Elena Perez Ceballos26*, Alejandro Marin27*, Belén Navarro28*, Ruben Fernandez Alvarez, MD29*, Pilar Gómez30*, Jose Antonio Hueso31*, Maria Jesus Penarrubia Ponce32*, Pilar Bravo33*, Daniel García Belmonte34*, Haridian De La Nuez Melian35*, Sara Nistal36*, Pau Abrisqueta Costa37*, Fernanda Ibañez38*, Luis Palomera, MD, PhD39*, Eva Donato40*, Andrea Provencio Rincon41*, Maria Stefania Infante, MD42* and Eva Gonzalez Barca43*

1Unit of Lymphoma. Department of Hematology. Son Espases University Hospital (IdISBa), Palma de Mallorca, Spain
2Hematology Department, Hospital Universitario Donostia, San Sebastian, ESP
3Hospital de Alcorcon, Alcorcon, ESP
4Hospital de Alcorcon, Alcorcon, Spain
5Hematology Department., Hospital Universitario Son Espases, IdISBa., Palma, Spain
6Hematology Department, Hospital Universitario Fundación Jiménez Díaz, LAS ROZAS, Spain
7Hospital de Cruces, Baracaldo( Vizcaya), ESP
8Hematology Department, Hospital Universitario Central de Asturias, Oviedo, Spain
9University Hospital Arnau de Vilanova, Lleida, Spain
10Hematology Department, Hospital Universitario 12 de Octubre, Madrid, Spain
11Hematology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain
12Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
13Hospital Universitario Nuestra Senora de Sonsoles, Avila, ESP
14Hospital Torre Cardenas, Torrecardenas, Spain
15Hospital de Elda, ELDA, Spain
16Hospital Universitario Virgen del Rocío, Seville, Spain
17Hospital Universitario Quirónsalud Madrid, Madrid, Spain
18Hematology Department, Hospital Universitario La Princesa, Madrid, Spain
19Hospital de Laredo, Laredo, Spain
20Servicio de Hematología. Hospital Universitario Lucus Augusti, Lugo, Spain
21Hospital de Pontevedra, Vigo, Pontevedra, ESP
22Hospital Universitario Dr.Balmis, Alicante, Spain
23Universidad CEU San Pablo, Madrid, Spain
24Clinical Hematology and Oncohematology, Hospital Universitario HM Sanchinarro, Madrid, Spain
25Hematology Department, Hospital Universitario Marqués de Valdecilla (IDIVAL), Santander, Spain
26Hospital Universitario Morales Meseguer, MURCIA, ESP
27Hospital Nuestra Señora de Candelaria, Tenerife, Spain
28Hematology Department, Hospital Universitario Puerta de Hierro, Majadahonda, Spain
29Hospital de Cabueñes, Gijón, Spain
30Hospital La Paz, Madrid, Spain
31Hospital de la Plana de Castellon, Castellon, Spain
32H. Clínico de Valladolid, Valladolid, ESP
33H. de Fuenlabrada, Fuenlabrada, Spain
34Hematology Department, Hospital Universitario la Zarzuela, Madrid, Spain
35Hospiral Dr. Negrin, Madrid, ESP
36H. de la Moncloa, Madrid, Spain
37University Hospital Vall d’Hebron, Barcelona, Spain
38H. de la Vega Baja, Orihuela, Spain
39Hospital Clinico Universitario Lozano Blesa, Instituto Investigacion Sanitaria Aragon, Zaragoza, Spain
40Hematology Department, Hospital Universitario Doctor Peset, Valencia, Spain
41Hospital de Manacor, Manacor, ESP
42HOSPITAL INFANTA LEONOR, Madrid, Madrid, ESP
43Department of Hematology, Department of Clinical Sciences, Institut Català d'Oncologia, Hospitalet de Llobregat, Barcelona University, Barcelona, Spain

Introduction

Therapy of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) remains challenging, particularly for ineligible patients for intensive therapy. Tafasitamab-lenalidomide (T/L) represents an effective treatment option based on the L-MIND, phase 2 trial findings. However, various real-world studies (RWS) have reported mixed outcomes. This study aims to describe the real-world outcomes of R/R DLBCL treated with T/L in Spain, focusing on prognostic factors influencing overall response rate (ORR), complete remission (CR), progression-free survival (PFS) and overall survival (OS), to determine the optimal practice setting for this therapy.

Methods

This retrospective multicenter RWS was conducted by the Spanish Group of Lymphoma (GELTAMO). Patients included were treated with T/L in an expanded access program opened in Spain from June 2021 to September 2022, and as per clinical practice from October 2022 to December 2023. To avoid selection bias, all patients who received at least one partial dose of Tafasitamab were included as in the intention to treat population (safety population). Efficacy was evaluated only in patients who had received at least one full cycle of the combined T/L therapy (efficacy population).

Results

Ninety-nine patients who received at least one dose of Tafasitamab were included, with 83 receiving at least one full cycle of T/L. The median age at T/L was 78 years (47-93), with 90% being older than 60 years; 32% had an ECOG PS>1; the median CIRS score was 6 (0-21); the median number of previous lines of therapy was 2 (1-13), with 45% relapsing after a previous CR and 55% progressing or refractory to the previous line. 76% of the patients in the safety cohort and 73% of the efficacy cohort would have not been eligible for the L-MIND trial. In the efficacy cohort, the median follow-up was 16 months (95%CI: 8-24). The ORR was 61%, with a CR of 42%. The median PFS was 10.9 months and median OS was 26.4 months, with 12m-PFS and OS rates of 44% and 60%, and 18m-PFS and OS of 43% and 56% respectively. PFS was significantly better in patients with ECOG PS 0-1 (HR 0.47; p=0.013), in those who received T/L in first or second relapse (HR 0.53; p=0.044) and non-refractory patients to the previous line (HR 0.48; p=0.024). Disease characteristics before T/L, age, CIRS or response after the first line, did not influence outcome. Patients obtaining a CR showed excellent outcomes with 18m-PFS and OS of 73% and 80%, respectively. Treatment was generally well-tolerated. The most common grade 3-4 adverse events were neutropenia (42%), infection (27%) and anemia (20%). A relative dose-intensity (RDI) of lenalidomide lower than 85% was associated with significantly worse PFS and OS.

Fifty-three (53%) patients died during the follow-up period. The primary causes of death were disease progression in 41 cases (77%). Eleven patients died due to toxicity or unrelated causes: 8 from infections (including 3 severe COVID19 pneumonia), two from secondary malignancies, one from progressive multifocal leukoencephalopathy and one for unknown causes.

Conclusions

In this real-world Spanish cohort treated with T/L, the treatment was well tolerated regardles age or comorbidities. The optimal setting for T/L appears to be in the first and second relapse, in patients who were not refractory to the previous line and with good ECOG PS (0-1). Age or CIRS have limited impact. RDI was associated with better PFS and OS. Patients achieving CR exhibited particularly favorable outcomes.

Disclosures: Zeberio: Incyte: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees. Morillo: Takeda: Honoraria; Roche: Honoraria, Other: Travel Funds; GSK: Honoraria; Kite: Other: Travel Funds. Jiménez Ubieto: Roche: Consultancy, Speakers Bureau; Novartis: Speakers Bureau; Janssen: Speakers Bureau; Sandoz: Speakers Bureau; Regeneron Pharmaceuticals, Inc.: Consultancy; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Lilly: Consultancy, Membership on an entity's Board of Directors or advisory committees; Incyte: Speakers Bureau; Kite-Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Genmab: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Bastos-Oreiro: Gilead: Honoraria, Research Funding; Abbvie: Honoraria, Research Funding; Astrazeneca: Honoraria; Sobi: Honoraria; Genmab: Honoraria; Lilly: Honoraria; Incyte: Honoraria; Kite: Honoraria, Research Funding; Janssen: Honoraria; Takeda: Honoraria; BMS: Honoraria; Roche: Honoraria, Research Funding. Rodríguez Garcia: MSD: Research Funding. Perez de Oteyza: Janssen: Consultancy; Roche: Consultancy, Speakers Bureau; Regeneron Pharmaceuticals, Inc.: Research Funding. Gonzalez Barca: AstraZeneca: Speakers Bureau; Roche: Speakers Bureau; Takeda: Speakers Bureau; Novartis: Consultancy; Beigene: Consultancy; Lilly: Consultancy; Incyte: Consultancy, Speakers Bureau; EUSAPharma: Consultancy, Other: Travel funding, Speakers Bureau; Kiowa: Consultancy, Speakers Bureau; Gilead: Consultancy; Abbvie: Consultancy, Other: Travel funding, Speakers Bureau; Janssen: Consultancy, Other: Travel funding, Speakers Bureau.

*signifies non-member of ASH