French early nationwide idecabtagene vicleucel chimeric antigen receptor T-cell therapy experience in patients with relapsed/refractory multiple myeloma (FENIX): A real-world IFM study from the DESCAR-T registry

B Ferment; J Lambert; D Caillot; I Lafon; L Karlin; A Lazareth; C Touzeau; X Leleu; N Moya; S Harel; A Perrot; P Bories; L Vincent; S Lamure; M Mohty; F Malard; S Manier; I Yakoub-Agha; J-M Schiano De Colella; G Brisou; A Talbot; O Decaux; R Houot; S Le Gouill; N Bigot; T Facon; J Corre; P Moreau; B Arnulf; Intergroupe Francophone du Myélome

doi:10.1111/bjh.19505

French early nationwide idecabtagene vicleucel chimeric antigen receptor T-cell therapy experience in patients with relapsed/refractory multiple myeloma (FENIX): A real-world IFM study from the DESCAR-T registry

Br J Haematol. 2024 May 15. doi: 10.1111/bjh.19505. Online ahead of print.

Authors

B Ferment^{1

2}, J Lambert³, D Caillot^{4

5}, I Lafon⁴, L Karlin⁶, A Lazareth⁶, C Touzeau⁷, X Leleu⁸, N Moya⁸, S Harel^{1

2}, A Perrot⁹, P Bories⁹, L Vincent¹⁰, S Lamure¹¹, M Mohty¹², F Malard¹², S Manier¹³, I Yakoub-Agha¹³, J-M Schiano De Colella¹⁴, G Brisou¹⁴, A Talbot^{1

2}, O Decaux¹⁵, R Houot¹⁵, S Le Gouill^{16

17}, N Bigot³, T Facon¹³, J Corre⁹, P Moreau⁷, B Arnulf^{1

2}; Intergroupe Francophone du Myélome

Affiliations

¹ Department of Immuno-Hematology, Hôpital Saint Louis, APHP/Université Paris Cité, Paris, France.
² Inserm U976 HIPI, Team 5: Lymphocyte Development and Lymphoid Disorders, Hôpital Saint Louis, Paris, France.
³ Biostatistics Department, Hôpital Saint Louis, APHP/Université Paris Cité, Paris, France.
⁴ Department of Hematology, Institut de Cancérologie de Bourgogne (ICB), Dijon, France.
⁵ Department of Hematology, Dijon University Hospital, Dijon, France.
⁶ Department of Hematology, Hospices Civils de Lyon, Lyon Sud University Hospital, Pierre-Benite, France.
⁷ Department of Hematology, Nantes University Hospital, Nantes, France.
⁸ Department of Oncology-Haematology and Cellular Therapy, Poitiers University Hospital, Poitiers, France.
⁹ Department of Hematology, IUCT Oncopole-Institut Universitaire du Cancer de Toulouse, Toulouse, France.
¹⁰ Department of Hematology, Montpellier University Hospital, Montpellier, France.
¹¹ Department of Hematology, Centre Léon Bérard, Lyon, France.
¹² Saint-Antoine Hospital, INSERM UMRs 938, Sorbonne University, Paris, France.
¹³ Department of Hematology, Lille Regional and University Hospital, Lille, France.
¹⁴ Department of Hematology, Institut Paoli Calmettes, Marseille, France.
¹⁵ Department of Hematology, Rennes University Hospital, Pontchaillou Hospital, Rennes, France.
¹⁶ Université Versailles Saint-Quentin, Versailles, France.
¹⁷ Department of Hematology, Institut Curie, Paris, France.

PMID: 38747092
DOI: 10.1111/bjh.19505

Abstract

Idecabtagene vicleucel (ide-cel), a chimeric antigen receptor T-cell therapy targeting B-cell maturation antigen (BCMA), received early access program (EAP) authorization in France in April 2021 for relapsed/refractory multiple myeloma (RRMM). We conducted a real-world registry-based multicentre observational study in 11 French hospitals to evaluate ide-cel outcomes. Data from 176 RRMM patients who underwent apheresis between June 2021 and November 2022 were collected from the French national DESCAR-T registry. Of these, 159 patients (90%) received ide-cel. Cytokine release syndrome occurred in 90% with 2% grade ≥3, and neurotoxicity occurred in 12% with 3% grade ≥3. Over the first 6 months, the best overall response and ≥complete response rates were 88% and 47% respectively. The median progression-free survival (PFS) from the ide-cel infusion was 12.5 months, the median overall survival (OS) was 20.8 months and the estimated OS rate at 12 months was 73.3%. Patients with extra-medullary disease (EMD) had impaired PFS (6.2 months vs. 14.8 months). On multivariable analysis, EMD and previous exposure to BCMA-targeted immunoconjugate or T-cell-redirecting GPRC5D bispecific antibody were associated with inferior PFS. Our study supports ide-cel's feasibility, safety and efficacy in real-life settings, emphasizing the importance of screening for EMD and considering prior treatments to optimize patient selection.

Keywords: cellular therapies; immunotherapy; multiple myeloma; real‐world experience.