Globenewswire·2025-12-08 06:30Core Insights - Galapagos NV announced promising Phase 2 data for GLPG5101, a CAR T-cell therapy for high-risk mantle cell lymphoma (MCL), showing high complete response rates and minimal residual disease negativity with durable responses [1][5] Group 1: Study Results - The ATALANTA-1 study reported an objective response rate (ORR) of 100% and a complete response rate (CRR) of 96% among infused patients [5] - At a median follow-up of 9 months, both duration of response (DOR) and progression-free survival (PFS) rates were 83% [5] - Among minimal residual disease (MRD)-evaluated patients, 90% were MRD-negative at complete response, with 7 out of 9 MRD-negative patients remaining in complete response at the data cut-off [5] Group 2: Safety Profile - GLPG5101 demonstrated a favorable safety profile, with the most common Grade ≥ 3 treatment-emergent adverse events being hematologic [5] - No Grade ≥ 3 cytokine release syndrome (CRS) was observed, and only one case of Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred [5] Group 3: Manufacturing and Administration - GLPG5101 is a second-generation anti-CD19/4-1BB CAR-T product administered as a single fixed intravenous dose, with a 7-day vein-to-vein time [1][4] - The study evaluated three dose levels: 50×10^6, 110×10^6, and 250×10^6 CAR+ viable T-cells [4] - The low dropout rate of 4% and elimination of the need for bridging therapy allowed more patients to access treatment [1][2] Group 4: Company Strategy - Galapagos intends to wind down its cell therapy activities while continuing to operate the business and conduct ongoing clinical studies [3] - The company remains open to viable proposals for acquiring all or part of its cell therapy business during the wind-down process [3]