Biomarkers of Efficacy and Safety of the Academic BCMA-CART ARI0002h for the Treatment of Refractory Multiple Myeloma.
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Oliver-Caldes Aina, Español-Rego Marta, Zabaleta Aintzane, González-Calle Verónica, Navarro-Velázquez Sergio, Inogés Susana, de Cerio Ascensión López-Díaz, Cabañas Valentín, López-Muñoz Nieves, Rodríguez-Otero Paula, Reguera Juan Luis, Moreno David F, Martínez-Cibrian Nuria, López-Corral Lucía, Pérez-Amill Lorena, Martin-Antonio Beatriz, Rosiñol Laura, Cid Joan, Tovar Natalia, Sáez-Peñataro Joaquín, López-Parra Miriam, Olesti Eulalia, Guillén Elena, Varea Sara, Rodríguez-Lobato Luis Gerardo, Battram Anthony M, González Marta Sonia, Sánchez-Salinas Andrés, González-Navarro Azucena, Ortiz-Maldonado Valentín, Delgado Julio, Prósper Felipe, Juan Manel, Martínez-López Joaquín, Moraleda José M, Mateos Maria Victoria, Urbano-Ispizua Álvaro, Paiva Bruno, Pascal Mariona, Fernández de Larrea Carlos
Аннотация
PATIENTS AND METHODS: We collected apheresis, final product, peripheral blood and bone marrow samples before and after infusion. We assessed BCMA, T-cell subsets, CART kinetics and antibodies, B-cell aplasia, cytokines, and measurable residual disease by next-generation flow cytometry, and correlated these to clinical outcomes.
RESULTS: At cut-off date March 17, 2023, with a median follow-up of 23.1 months (95% CI, 9.2-37.1), overall response rate in the first 3 months was 95% [95% confidence interval (CI), 89.5-100]; cytokine release syndrome (CRS) was observed in 90% of patients (5% grades ≥3) and grade 1 immune effector cell-associated neurotoxicity syndrome was reported in 2 patients (3%). Median progression-free survival was 15.8 months (95% CI, 11.5-22.4). Surface BCMA was not predictive of response or survival, but soluble BCMA correlated with worse clinical outcomes and CRS severity. Activation marker HLA-DR in the apheresis was associated with longer progression-free survival and increased exhaustion markers correlated with poorer outcomes. ARI0002h kinetics and loss of B-cell aplasia were not predictive of relapse.
CONCLUSIONS: Despite deep and sustained responses achieved with ARI0002h, we identified several biomarkers that correlate with poor outcomes.