Galapagos Presented New Data at ICML 2025 From Cohort 3 of ATALANTA-1 in Relapsed/Refractory Indolent NHL Patients, Demonstrating High Complete Response and MRD Negativity Rates With CAR-T Candidate GLPG5101

Core Insights - The ATALANTA-1 Phase 1/2 study of GLPG5101 shows promising efficacy and safety in treating relapsed/refractory indolent non-Hodgkin lymphoma, with a 97% complete response rate and 100% minimal residual disease negativity in evaluable patients [1][3][4] - The study highlights the advantages of a decentralized manufacturing platform, allowing for fresh CAR-T cell administration within seven days, which mitigates disease progression risks and spares patients from additional chemotherapy [2][5] Efficacy and Safety - In Cohort 3, 34 patients were enrolled, with 32 receiving GLPG5101; 94% received fresh CAR-T cells, and 93% were treated within seven days of manufacturing [1][3] - The complete response rate was 97%, with 31 out of 32 patients responding to treatment, and 100% of evaluable patients being MRD negative [3][4] - The 12-month progression-free survival rate was reported at 97%, with no relapses noted [3][4] Manufacturing and Administration - The decentralized manufacturing platform enables a median vein-to-vein time of seven days, allowing for timely treatment without the need for cytotoxic bridging therapy [2][5] - The final product showed a significant increase in early phenotype CD4+ and CD8+ CAR-T cells compared to the starting material [3] Study Design and Objectives - The ATALANTA-1 study is evaluating GLPG5101 in multiple hematological malignancies, focusing on safety, efficacy, and the feasibility of decentralized manufacturing [4] - The primary objective of the Phase 1 part is to assess safety and determine the recommended dose for Phase 2, while the Phase 2 part aims to evaluate the Objective Response Rate [4]