Galapagos presents new data from ATALANTA-1 trial

Galapagos (GLPG) presented new data from the ongoing ATALANTA-1 Phase 1/2 study of its investigational CD19 CAR T-cell therapy, GLPG5101, in an oral presentation at the 18th International Conference on Malignant Lymphoma. These data demonstrate high complete response and minimal residual disease rates in heavily pretreated relapsed/refractory indolent non-Hodgkin lymphoma patients. Additionally, with a rapid vein-to-vein time enabled by Galapagos’ decentralized manufacturing platform, 93% of patients treated in the study received fresh, non-cryopreserved GLPG5101, without the need for cytotoxic bridging therapy. The oral presentation at ICML features new safety, efficacy and manufacturing data for GLPG5101 from the completely enrolled cohort in R/R indolent NHL of the ongoing ATALANTA-1 Phase 1/2 study. As of the October 14, 2024 data cut-off, 34 patients with R/R iNHL underwent leukapheresis, of whom 32 received an infusion of GLPG5101. Of those 32 patients: 94% received a fresh product; 93% received it with a seven-day vein-to-vein time, avoiding the need for cytotoxic bridging therapy; 6% received a cryopreserved product with a 13-day vein-to-vein time. The proportion of early phenotype CD4+ and CD8+ CAR-T cells increased significantly in the final product versus starting material. GLPG5101 showed a efficacy profile with robust and durable CAR-T cell expansion: At month 9, 100% of evaluable patients had persisting CAR-T cells and CAR-T cells were detected up to 21 months. A complete response rate of 97% was observed with 31/32 infused patients responding to treatment and 100% of evaluable patients being MRD negative at time of CR. The 12-month progression free survival rate was 97%, with no reported relapses. The majority of Grade 3 treatment emergent adverse events were hematological. Cases of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome were few and predominantly low-grade with only a single Grade 3 report of ICANS. There were no deaths reported.