CT-198 Pooled Fecal Allogeneic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Early Access Program in Europe - Université de Picardie Jules Verne
Article Dans Une Revue Clinical Lymphoma, Myeloma & Leukemia Année : 2024

CT-198 Pooled Fecal Allogeneic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Early Access Program in Europe

Michael Tees
  • Fonction : Auteur
Faezeh Faezeh
  • Fonction : Auteur
Martin Martiné
  • Fonction : Auteur
Sylvain Chantepie
  • Fonction : Auteur
Jakob Rudzki
  • Fonction : Auteur
Marie-Anne Anne Couturier
  • Fonction : Auteur
Patrice Ceballos
  • Fonction : Auteur
Clémence Médiavilla
  • Fonction : Auteur
David Beauvais
  • Fonction : Auteur
Etienne Daguindau
  • Fonction : Auteur
Karin Bilger
  • Fonction : Auteur
Stefan Klein
  • Fonction : Auteur
Pedro Chorao
  • Fonction : Auteur
Sarah Guenounou
  • Fonction : Auteur
Francesca Patriarca
  • Fonction : Auteur
Marion Bruelle
  • Fonction : Auteur
Emilie Plantamura
  • Fonction : Auteur
Mohamad Mohty
  • Fonction : Auteur

Résumé

Introduction We report clinical outcomes from 140 steroid-refractory (SR) or steroid-dependent (SD) GI-aGvHD patients treated with the pooled allogeneic microbiotherapy MaaT013 as part of the Early Access Program (EAP) in Europe. Patients and Methods The 140 patients with SR/SD GI-aGvHD, who had been treated unsuccessfully with 1 to 6 systemic lines, received MaaT013 therapy. For each patient, a total of 3 MaaT013 administrations were planned every 7 ± 2 days. Results The GI objective response rate (GI-ORR) on day 28 (D28) was 52%: 39 complete responses (CR, 28%), 26 very good partial responses (19%), 8 partial responses (PR, 6%). OS was 54% at month 6 (M6), 47% at M12, and 42% at M18. OS was significantly higher in patients achieving at least GIPR at D28 (Responder, R; n=73) than in patients with treatment failure (Non-responder, NR; n=67): 74% versus 33% at M6, 68% versus 24% at M12, 58% versus 24% at M18 (P<.0001). GI-ORR was higher in 49 patients previously treated with ruxolitinib (2nd line) and MaaT013 (3rd line): 63% at D28, with 49% CR. OS was 52% at M6, 49% at M12, and 42% at M18. OS was significantly higher in R patients than in NR patients (M6, 76% versus 11%; M12, 76% versus 6%, M18, 64% versus 6% for R and NR respectively, P<.0001). MaaT013 displayed a good overall safety profile: 22 pharmacovigilance cases were considered possibly related to MaaT013 by either the physician or the company: sepsis in 6, bacteremia in 10, rectal bleeding in 3, Clostridioides difficile colitis in 1, Escherichia coli osteoarthritis in 1, Geotrichum silvicola in stools in 1. No pathogen transmission was reported. In 2 patients, non-pathogenic commensal bacteria isolated following infectious events were detected in the administered MaaT013. Causality could not be formally excluded in these cases. No death was related to MaaT013 administration. Conclusion EAP clinical data showed that MaaT013 was safe and effective for the treatment of SR/SD-GI-aGvHD, especially after ruxolitinib failure. GI response correlated with increased OS, suggesting a favorable benefit-risk profile for MaaT013. A Phase 3 trial is currently ongoing to confirm these results in ruxolitinib-refractory patients (NCT04769895).
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Dates et versions

hal-04681566 , version 1 (29-08-2024)

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Citer

Florent Malard, Michael Tees, Thomas Cluzeau, Faezeh Faezeh, Anne Huynh, et al.. CT-198 Pooled Fecal Allogeneic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Early Access Program in Europe. Clinical Lymphoma, Myeloma & Leukemia, 2024, 24, pp.S590-S591. ⟨10.1016/S2152-2650(24)01746-4⟩. ⟨hal-04681566⟩
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