Galapagos(GLPG) Newsfilter·2024-06-14 20:01GLPG5101 Clinical Trial Data - GLPG5101, a CD19 CAR-T candidate, showed promising results in the Phase 1/2 ATALANTA-1 study for relapsed/refractory non-Hodgkin lymphoma (R/R NHL) [1] - As of December 20, 2023, 34 patients (17 in Phase 1 and 17 in Phase 2) received GLPG5101 with a median vein-to-vein time of seven days [3] - In Phase 1, 14 of 16 efficacy-evaluable patients responded to treatment (ORR 87.5%), with 12 achieving a complete response (CRR 75%) [16] - In Phase 2, 14 of 15 efficacy-evaluable patients responded to treatment (ORR 93.3%), with all responders achieving a complete response (CRR 93.3%) [16] - High ORR and CRR were observed across different lymphoma types: DLBCL (ORR 78%, CRR 56%), FL/MZL (ORR and CRR 94%), and MCL (ORR and CRR 100%) [16] - Durable responses were observed, with 71% of Phase 1 patients and 100% of Phase 2 patients maintaining responses at data cut-off [16] GLPG5101 Safety Profile - GLPG5101 demonstrated an encouraging safety profile, with most treatment-emergent adverse events (TEAEs) being Grade 1 or 2 [16] - Two cases of Grade 3 cytokine release syndrome (CRS) were observed in Phase 1, and one case of Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in Phase 2 [16] - No unexpected safety findings were observed as of the data cut-off date [10] Galapagos' T-Cell Manufacturing Platform - The company's decentralized T-cell manufacturing platform enables a median vein-to-vein time of seven days, eliminating the need for bridging therapy [2] - The platform consists of xCellit® workflow management software, Lonza's Cocoon® automated manufacturing system, and proprietary quality control testing [6] - The final CAR-T product showed a higher proportion of early phenotypes of CD4+ and CD8+ CAR T cells compared to starting material, indicating improved cell quality during manufacturing [2] Non-Hodgkin Lymphoma Overview - Non-Hodgkin lymphoma is a cancer originating from lymphocytes, with B-cell lymphoma accounting for about 85% of cases in the US [5] - The disease can be aggressive (fast-growing) or indolent (slow-growing), with prognosis and treatment depending on the stage and type [5] Presentation Details - The new data will be presented at the European Hematology Association (EHA) 2024 Hybrid Congress by Marie José Kersten, M.D. [18] - The presentation will include updated safety and efficacy data for GLPG5101 in patients with DLBCL, FL, MZL, and MCL, as well as durability and cellular kinetics data [10]