Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 110

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 4
Chunk 110
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 15 Phase 1 batches were manufactured using Galapagos’ decentralized platform and infused as a single fresh, fit product within a median vein-to-vein time of seven days, with 80% of patients receiving the product in seven days. Safety and efficacy results were available for 15 patients. 
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The results are summarized below: 
•Overall, 13 of 15 efficacy evaluable patients responded to treatment (Objective Response Rate (ORR) of 93%) and 10 of 15 patients achieved a Complete Response (CRR of 66.7%). 8 of 9 patients with RT responded to treatment (ORR of 89%) and 6 of 9 RT patients achieved a Complete Response (CRR of 67 %). At time of analysis, 10 of 13 of responding patients (77%) were in ongoing response with a median follow-up of 6 months; 2 of 3 patients who progressed after an initial response had confirmed CD19-negative disease.
•At the higher dose level (DL2), 8 of 8 patients responded to treatment (ORR of 100%), 5 of 8 patients achieved a Complete Response (CRR of 63%), and 6 of 6 patients with RT responded to treatment (ORR of 100%). 
•GLPG5201 showed an encouraging safety profile with most treatment emergent adverse events (TEAEs) of Grade 1 or 2, mostly hematological. Cytokine release syndrome (CRS) Grade 1 or 2 was observed in 53% of the patients, and no CRS Grade ≥ 3 or any immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. Two deaths occurred in patients with RT: one event of cytomegalovirus colitis 14.5 months post-infusion in a patient with complete response (CR), and one death due to disease progression 110 days post-infusion. 
•The proportion of early T-cell phenotypes was higher in the final product (FP) compared with leukapheresis starting material (SM): CD4+ T cells median (range) change +23.6% (−17.9 to 39.3), with an increase observed in 10 out of 13 patients; CD8+ T cells median (range) change +50.8% (7.6 to 73.3), with an increase observed in 13 out of 13 patients. The ratio